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Search Results for QA Specialist
Job Title. Location Salary Actions

Quality Assurance Specialist (hybrid)

Quality Assurance Specialist (hybrid) RK4599 Contract 12 months Dublin We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties: Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities for Aseptic products, ensuring that all activities meet company and regulatory e...

Location: Dublin,
Quality Assurance Specialist (hybrid) 		Dublin Not Disclosed

Quality Specialist & Deputy RP

Quality Specialist & Deputy RP Our client, a healthcare service provider, are currently recruiting for a Quality Specialist & Deputy RP to join their team on a permanent basis. As Quality Specialist & Deputy RP you will support the businesses QMS along with the development and implementation of processes and systems to maintain compliance with the GxP requirement and ISO 9001 2015 requirements . This role is based in Limerick with travel to other sites in Ireland so a full drivers licence is required. Responsibilities Support the maintenance ...

Location: Limerick,
Quality Specialist & Deputy RP 		Limerick Not Disclosed

Senior QA Specialist (hybrid)

Senior QA Specialist (hybrid) RK23762 11 Months Tipperary We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Tipperary. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. As a Senior QA Specialist, you will be a key driver of quality assurance activities at our site, ensuring that all operations align with cGMP principles and regulatory expectations from agencies such as the FDA and EMEA. You will take ownership of main...

Location: Tipperary,
Senior QA Specialist (hybrid) 		Tipperary Not Disclosed

Senior Quality Systems Engineer

Role: Senior Quality Systems Engineer Location: ATU Ihub - Galway Benefits: Top salary, hybrid working, bonus, pension and Shares Company: Brand new Medical Device start up with exciting new adventure. Role: Senior Quality Systems Engineer you will play a key role in the Set up, implementation and maintenance of the company’s Quality Management System.This is a fantastic opportunity, which will allow you to work as part of a supportive, collaborative team in...

Location: Galway, Galway City,
Senior Quality Systems Engineer 		Galway Not Disclosed

Design Quality Engineer

Role: Design Assurance Engineer Location: Oranmore, Galway Benefits: Excellent salary, pension, healthcare and yearly bonus Company: My client is a Medical Device company developing highly innovative non-surgical interventions that treat chronic inflammatory Sino-Nasal diseases. They are looking for 2 Design Assurance Engineers to work on a Product development stage Next Gen device - currently in concept phase plan to move into design & development Feb/March 2023. Also an Existing device – commercially released but iterative chan...

Location: Galway, Galway City,
Design Quality Engineer 		Galway Not Disclosed

Associate Director Site Data Integrity Lead

Associate Director Site Data Integrity Lead Our client, a global biopharmaceutical manufacturer are currently recruiting an experienced Associate Director Site Data Integrity Lead to join their team on a permanent basis. Responsibilities: Oversee quality governance for electronic and computerized systems (e.g., MES, DeltaV, LIMS, ELN, SAP) Lead implementation of data integrity and computer system validation (CSV) processes Manage validation lifecycle, change control, deviations, and CAPAs Support regulatory inspections and maintain inspection re...

Location: Limerick,
Associate Director Site Data Integrity Lead 		Limerick Not Disclosed

Senior Quality Systems Engineer

Role: Senior Quality Systems Engineer Location: Parkmore, Galway (Hybrid working) Benefits: Top salary, hybrid working, bonus, pension and healthcare Company: My client are a growing Medical Device company who have recently moved into a high tech new site in Parkmore. They have developed an innovative new technology to improve the performance of Vascular stents. Role: Reporting to the Quality Systems Manager, as a Senior Quality Systems Engineer you will play a key role in the implementation and maintenance o...

Location: Galway, Galway City,
Senior Quality Systems Engineer 		Galway Not Disclosed

Design Assurance Engineer

Job title: Design Assurance Engineer Location: Parkmore Business Park, Galway (Hybrid working 2 days a week on site) Benefits: Competitive salary, 10% bonus, Hybrid working, Full family healthcare, flexible working hours and pension contribution. Also an excellent opportunity to build your career with an exciting Medical Device company going through a growth phase. Company: My client are a rapidly growing medical device company offering a highly differentiated solution in SFA interventions. Their culture of innovation helps each individual develop...

Location: Clare, Galway, Galway City, Limerick, Limerick City,
Design Assurance Engineer 		EU Not Disclosed

Reg Affairs Specialist

Role: Regulatory Affairs Engineer Location: Parkmore, Galway (Hybrid working) Benefits: Top salary Company: My client are a growing Medical Device company who have recently moved into a high tech new site in Parkmore. They have developed an innovative new technology to improve the performance of Vascular stents. Role: Reporting to the Senior Regulatory Affairs Manager, as a Regulatory Affairs Specialist you will play a key a key role in the implementation of post-market activities within Veryan. This is a ...

Location: Connaught, Galway, Galway City, Leitrim, Limerick,
Reg Affairs Specialist 		EU Not Disclosed

Design Assurance Engineer

Job title: Design Assurance Engineer Location: Parkmore Business Park, Galway (Hybrid working 2 days a week on site) Benefits: Competitive salary, 10% bonus, Hybrid working, Full family healthcare, flexible working hours and pension contribution. Also an excellent opportunity to build your career with an exciting Medical Device company going through a growth phase. Company: My client are a rapidly growing medical device company offering a highly differentiated solution in SFA interventions. Their culture of innovation helps each individual develop...

Location: Clare, Galway, Galway City, Limerick, Limerick City,
Design Assurance Engineer 		EU Not Disclosed

Quality Engineer

Job title : Quality Engineer Location: Galway Business Park, Dangan Benefits: Competitive salary, 10% bonus, Share options, excellent opportunity to develop your experience and career in an exciting start up helping develop a product from its very early stages. Company: My client an early-stage medical device start-up company focused on the design and development of novel devices for the treatment of Intracranial Atherosclerotic Disease. This is a new and evolving treatment area likely to be the next frontier in Neuro-intervention. ...

Location: Galway, Galway City,
Quality Engineer 		Galway Not Disclosed

Quality Engineer

Job title : Quality Engineer Location: Galway Business Park, Dangan Benefits: Competitive salary, 10% bonus, Share options, excellent opportunity to develop your experience and career in an exciting start up helping develop a product from its very early stages. Company: My client an early-stage medical device start-up company focused on the design and development of novel devices for the treatment of Intracranial Atherosclerotic Disease. This is a new and evolving treatment area likely to be the next frontier in Neuro-intervention. ...

Location: Galway, Galway City,
Quality Engineer 		Galway Not Disclosed

Senior Design Assurance Engineer

Job title: Senior Design Assurance Engineer Location: Parkmore Business Park, Galway (Hybrid working 2 days a week on site) Benefits: Competitive salary, 10% bonus, Hybrid working, Full family healthcare, flexible working hours and pension contribution. Also an excellent opportunity to build your career with an exciting Medical Device company going through a growth phase. Company: My client are a rapidly growing medical device company offering a highly differentiated solution in SFA interventions. Their culture of innovation helps each indi...

Location: Athlone, Clare, Connaught, Galway, Galway City,
Senior Design Assurance Engineer 		EU Not Disclosed

Quality Engineer

Job title : Quality Engineer Location: Galway Business Park, Dangan Benefits: Competitive salary, 10% bonus, Share options, excellent opportunity to develop your experience and career in an exciting start up helping develop a product from its very early stages. Company: My client an early-stage medical device start-up company focused on the design and development of novel devices for the treatment of Intracranial Atherosclerotic Disease. This is a new and evolving treatment area likely to be the next frontier in Neuro-intervention. ...

Location: Galway, Galway City,
Quality Engineer 		Galway Not Disclosed

Quality Engineer

Job title : Quality Engineer Location: Galway Business Park, Dangan Benefits: Competitive salary, 10% bonus, Share options, excellent opportunity to develop your experience and career in an exciting start up helping develop a product from its very early stages. Company: My client an early-stage medical device start-up company focused on the design and development of novel devices for the treatment of Intracranial Atherosclerotic Disease. This is a new and evolving treatment area likely to be the next frontier in Neuro-intervention. ...

Location: Galway, Galway City,
Quality Engineer 		Galway Not Disclosed

Quality Engineer

Job title : Quality Engineer Location: Galway Business Park, Dangan Benefits: Competitive salary, 10% bonus, Share options, excellent opportunity to develop your experience and career in an exciting start up helping develop a product from its very early stages. Company: My client an early-stage medical device start-up company focused on the design and development of novel devices for the treatment of Intracranial Atherosclerotic Disease. This is a new and evolving treatment area likely to be the next frontier in Neuro-intervention. ...

Location: Galway, Galway City,
Quality Engineer 		Galway Not Disclosed

Quality Engineer

Job title : Quality Engineer Location: Galway Business Park, Dangan Benefits: Competitive salary, 10% bonus, Share options, excellent opportunity to develop your experience and career in an exciting start up helping develop a product from its very early stages. Company: My client an early-stage medical device start-up company focused on the design and development of novel devices for the treatment of Intracranial Atherosclerotic Disease. This is a new and evolving treatment area likely to be the next frontier in Neuro-intervention. ...

Location: Galway, Galway City,
Quality Engineer 		Galway Not Disclosed

Quality Engineer

Job title : Quality Engineer Location: Galway Business Park, Dangan Benefits: Competitive salary, 10% bonus, Share options, excellent opportunity to develop your experience and career in an exciting start up helping develop a product from its very early stages. Company: My client an early-stage medical device start-up company focused on the design and development of novel devices for the treatment of Intracranial Atherosclerotic Disease. This is a new and evolving treatment area likely to be the next frontier in Neuro-intervention. ...

Location: Galway, Galway City,
Quality Engineer 		Galway Not Disclosed

Quality Specialist

Job title: Quality Assurance Specialist Location: Western Business Park, Shannon, Co. Clare Benefits: Good salary, Healthcare, pension, 25 days holidays, opportunity to grow your career with exciting Medical Device company working on projects from concept. Summary: The Quality Systems specialist role will involve supporting the development and implementation of the Quality Management System with my Medical Device client in order to maintain 2017/745(MDR), ISO 13485, ISO 14971, ISO 9001 and FDA QSR standards and requirements. The QMS includes m...

Location: Clare, Limerick, Limerick City, Republic of Ireland,
Quality Specialist 		EU Not Disclosed

Quality Engineer

Job title : Quality Engineer II Location: Galway Business Park, Dangan Benefits: Competitive salary, 10% bonus, Share options, excellent opportunity to develop your experience and career in an exciting start up helping develop a product from its very early stages. Company: My client an early-stage medical device start-up company focused on the design and development of novel devices for the treatment of Intracranial Atherosclerotic Disease. This is a new and evolving treatment area likely to be the next frontier in Neuro-intervention. Overview...

Location: Galway, Galway City,
Quality Engineer 		Galway Not Disclosed

Quality Specialist

Job title: Quality Assurance Specialist Location: Western Business Park, Shannon, Co. Clare Benefits: Good salary, Healthcare, pension, 25 days holidays, opportunity to grow your career with exciting Medical Device company working on projects from concept. Summary: The Quality Systems specialist role will involve supporting the development and implementation of the Quality Management System with my Medical Device client in order to maintain 2017/745(MDR), ISO 13485, ISO 14971, ISO 9001 and FDA QSR standards and requirements. The QMS includes m...

Location: Clare, Limerick, Limerick City, Republic of Ireland,
Quality Specialist 		EU Not Disclosed

Quality Engineer

Job title : Quality Engineer Location: Galway Business Park, Dangan Benefits: Competitive salary, 10% bonus, Share options, excellent opportunity to develop your experience and career in an exciting start up helping develop a product from its very early stages. Company: My client an early-stage medical device start-up company focused on the design and development of novel devices for the treatment of Intracranial Atherosclerotic Disease. This is a new and evolving treatment area likely to be the next frontier in Neuro-intervention. ...

Location: Galway, Galway City,
Quality Engineer 		Galway Not Disclosed

Quality Engineer

Job title : Quality Engineer Location: Galway Business Park, Dangan Benefits: Competitive salary, 10% bonus, Share options, excellent opportunity to develop your experience and career in an exciting start up helping develop a product from its very early stages. Company: My client an early-stage medical device start-up company focused on the design and development of novel devices for the treatment of Intracranial Atherosclerotic Disease. This is a new and evolving treatment area likely to be the next frontier in Neuro-intervention. ...

Location: Galway, Galway City,
Quality Engineer 		Galway Not Disclosed

Quality Specialist

Job title: Quality Assurance Specialist Location: Western Business Park, Shannon, Co. Clare Benefits: Good salary, Healthcare, pension, 25 days holidays, opportunity to grow your career with exciting Medical Device company working on projects from concept. Summary: The Quality Systems specialist role will involve supporting the development and implementation of the Quality Management System with my Medical Device client in order to maintain 2017/745(MDR), ISO 13485, ISO 14971, ISO 9001 and FDA QSR standards and requirements. The QMS includes m...

Location: Clare, Limerick, Limerick City, Republic of Ireland,
Quality Specialist 		EU Not Disclosed

Quality Assurance Engineer

JOB TITLE: Quality Assurance Engineer LOCATION: Castlerea, Roscommon (On site) BENEFITS: Good salary, 5% bonus, Healthcare and pension SUMMARY: Reporting to the Quality Engineering Manager, the Quality Assurance Engineer will provide ongoing Quality support in an effort to maximise production quality performance, including identifying root cause, implementing corrective/preventive action on all quality issues in production. Scope of role will also include addressing any customer and internal related issues identified in the manufacturing ...

Location: Longford, Midlands, Roscommon, Sligo, Westmeath,
Quality Assurance Engineer 		EU Not Disclosed

Validation Engineer

Role: Validation Engineer Location: Carrick on Shannon, Leitrim Benefits: Competitive salary, Bonus, pension, healthcare and hybrid working Company: Work with theLargest employer in Leitrim show specialise in making Catheters all inhouse. Work in a company have cleanrooms dedicated to customers, very specialised. Generally have about 100 promotions per year – Projects involved, individual plans, goal setting, leadership training. Responsibilities Ensuring that product introductions & change controls ar...

Location: Athlone, Cavan, Connaught, Donegal, Leitrim,
Validation Engineer 		EU Not Disclosed

Quality Engineer

Role: Quality Engineer Location: Carrick on Shannon, Leitrim Benefits: Competitive salary, Bonus, pension, healthcare and hybrid working Company: Work with theLargest employer in Leitrim show specialise in making Catheters all inhouse. Work in a company have cleanrooms dedicated to customers, very specialised. Generally have about 100 promotions per year – Projects involved, individual plans, goal setting, leadership training. Responsibilities Assist with the implementation and development of the site QMS in line with the ...

Location: Athlone, Connaught, Leitrim, Longford, Midlands,
Quality Engineer 		EU Not Disclosed

QA Manager

QA MANAGER Our client a Canadian based early stage pharma company are currently seeking a QA Manager to join their team. Role is with an innovative company who are currently scaling up manufacturing and looking for a strong Quality professional to join them on the journey. Relocation and visa assistance will be provided Role/Responsibilities: • Ensure facility is compliant to GMP expectations for manufacture, storage, distribution, and testing of drug product. • Perform comprehensive oversight related to manufacturing/ packaging comp...

Location: Canada,
QA Manager 		Canada €100000+

Senior Quality Engineer

Role: Senior Quality Engineer Location: Carrick on Shannon, Leitrim Benefits: Competitive salary, Bonus, pension and healthcare Company: Work with theLargest employer in Leitrim show specialise in making Catheters all inhouse. Work in a company have cleanrooms dedicated to customers, very specialised. Generally have about 100 promotions per year – Projects involved, individual plans, goal setting, leadership training. Responsibilities Integration & Maintenance of the Quality Management System with all Freudenberg Medica...

Location: Leitrim, Longford, Roscommon,
Senior Quality Engineer 		Leitrim Not Disclosed

QA Engineer

Role: QA Engineer (Validation) Location: Carrick on Shannon, Leitrim Benefits: Competitive salary, Bonus, pension and healthcare Company: Work with theLargest employer in Leitrim show specialise in making Catheters all inhouse. Work in a company have cleanrooms dedicated to customers, very specialised. Generally have about 100 promotions per year – Projects involved, individual plans, goal setting, leadership training. Responsibilities Ensuring that product introductions & change controls are effectively managed...

Location: Leitrim, Longford, Midlands, Roscommon,
QA Engineer 		EU Not Disclosed

Quality Technician

Title: Quality Technician Location : The Digital Hub, Rainsford St, Dublin 8. Benefits: Competitive salary, Health insurance and Hybrid working Company: My client are a Medical Device company who started up in 2010 and have developed and patented a bimodal neuromodulation technology that it is evaluating for neurological disorders. The lead application of this technology is through a device which has been shown to soothe and relieve tinnitus, a condition affecting 10% of the adult ...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Quality Technician 		EU Not Disclosed

Validation & Verification Engineer

Title: Product Development Engineer (Validation & Verification) Location: The Digital Hub, Rainsford St, Dublin 8. Benefits: Excellent salary, flexible working hours and Health insurance Role: As a Product Development Engineer you will gain exposure to a range of technologies at the forefront of biomedical research and every phase of the product development lifecycle from initial concept development through to commercialisation. Expand its engineering department to support development of flagship and next-generation medical device products that comb...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Validation & Verification Engineer 		EU Not Disclosed

Quality Technician

Title: Quality Technician Location : The Digital Hub, Rainsford St, Dublin 8. Benefits: Competitive salary, Health insurance and Hybrid working Company: My client are a Medical Device company who started up in 2010 and have developed and patented a bimodal neuromodulation technology that it is evaluating for neurological disorders. The lead application of this technology is through a device which has been shown to soothe and relieve tinnitus, a condition affecting 10% of the adult population and commonly known as 'ringing in the ears'. Having launched in...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Quality Technician 		EU Not Disclosed

Quality Technician

Title: Quality Technician Location : The Digital Hub, Rainsford St, Dublin 8. Benefits: Competitive salary, Health insurance and Hybrid working Company: My client are a Medical Device company who started up in 2010 and have developed and patented a bimodal neuromodulation technology that it is evaluating for neurological disorders. The lead application of this technology is through a device which has been shown to soothe and relieve tinnitus, a condition affecting 10% of the adult population and commonly known as 'ringing in the ears'. Having launched in...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Quality Technician 		EU Not Disclosed

Senior Quality Engineer

Job title: Senior Quality Assurance Engineer Location: Oranmore, Galway Benefits: Excellent salary, Income Protection, Life Assurance, Contribution of €2,000 per annum in lieu of health insurance, Pension Scheme, Annual discretionary bonus up to 10%, Educational Assistance, Employee Referral Programme, Cycle to Work Scheme, Sports & Social Activities Role: As a Senior Quality Engineer you will be responsible for implementing and promoting best in class quality assurance through the product lifecycle for my client device. C...

Location: Galway, Galway City,
Senior Quality Engineer 		Galway Not Disclosed

Quality Manager - NPI

Role: Quality Manager - NPI Based in Dun Laoghaire – on site role Benefits: Competitive salary, Healthcare, bonus or share options and Pension contribution, excellent opportunity to expand your career in exciting Medical Device company growing from strength to strength. Company: My client have deep expertise and advanced technologies to continuously innovate their pen needles, insulin syringes and other products. Job Purpose: To provide support for ISO9000/ISO13485 Quality System. Responsible for ensuring adherence to al...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Quality Manager - NPI 		EU Not Disclosed

Quality Manager

Role: Quality Manager - NPI Based in Dun Laoghaire – on site role Benefits: Competitive salary, Healthcare, bonus or share options and Pension contribution Company: My client have leveraged deep expertise and advanced technologies to continuously innovate their pen needles, insulin syringes and other products. They offer an excellent opportunity for anyone looking to grow their career in the Medical Device industry. Job Purpose: To provide support for ISO9000/ISO13485 Quality System. Responsible for ensuring adher...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North,
Quality Manager 		EU Not Disclosed

Senior Quality Engineer

Title: Senior Quality Engineer Location: Dublin 1 (Hybrid working) Company: My client are developing a Best-In-Class minimally invasive solution for severe Tricuspid Regurgitation (TR).It is a clear unmet clinical need, with a significant impact on mortality, cardiovascular events and quality of life. With a prevalence greater than aortic stenosis in the population over 65 years, TR is the next structural heart opportunity. Responsibilities: Support the development, implementation, and maintenance of the QMS in accordance with relevant st...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Senior Quality Engineer 		EU Not Disclosed

Quality Engineer

Role: Quality Engineer Location: Mullingar, Westmeath (On site) Benefits: Good salary, pension, healthcare and yearly bonus. Company: My client are an exciting business located in a modern state of the art facility in Mullingar Co. Westmeath. Passionate about serving the world’s medical device and allied healthcare industries in offering a range of the highest quality innovative healthcare packaging solutions. Role: Reporting to the Senior Quality engineer and/or Quality and Regulatory Director the Quality Engineer will work in collaboration with the s...

Location: Athlone, Cavan, Dublin, Kildare, Longford,
Quality Engineer 		EU Not Disclosed

Quality Systems Manager

Company: My client are have a global portfolio which includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. They are committed to helping create healthier communities worldwide through education, outreach and better access to treatment Role: Quality Systems Manager - Senior Location: Newenham Court, Northern Cross, Malahide rd, Dublin 17 Team: 6 direct reports Hybrid working: 2-3 days a week on site per week Benefits: Compe...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Quality Systems Manager 		EU Not Disclosed

Senior Quality Engineer

Title: Senior Quality Engineer Location: Dublin 1 (Hybrid working) Company: My client are developing a Best-In-Class minimally invasive solution for severe Tricuspid Regurgitation (TR).It is a clear unmet clinical need, with a significant impact on mortality, cardiovascular events and quality of life. With a prevalence greater than aortic stenosis in the population over 65 years, TR is the next structural heart opportunity. Responsibilities: Support the development, implementation, and maintenance of the QMS in accordance with relevant st...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Senior Quality Engineer 		EU Not Disclosed

Quality Engineer

Role: Quality Engineer Location: Mullingar, Westmeath (On site) Benefits: Good salary, pension, healthcare and yearly bonus. Company: My client are an exciting business located in a modern state of the art facility in Mullingar Co. Westmeath. Passionate about serving the world’s medical device and allied healthcare industries in offering a range of the highest quality innovative healthcare packaging solutions. Role: Reporting to the Senior Quality engineer and/or Quality and Regulatory Director the Quality Engineer will work in collaboration with the s...

Location: Athlone, Cavan, Dublin, Kildare, Longford,
Quality Engineer 		EU Not Disclosed

Quality Specialist

Our client, a long established and dynamic company, providing professional services to the lifesciences sector, now has a really nice opportunity for a Quality Specialist to join their growing team. The role will involve ongoingmaintenance of all quality standards (ISO, BRC, GMP+, ESAD etc.), management of the Vendor Approval Process, including completion of questionnaires (MSQ/VSQ), assistance with audits and overall management of the quality system of the business. This is a really nice opening to join a highly reputable company, while growing y...

Location: Tipperary,
Quality Specialist 		Tipperary Not Disclosed
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Career Profile

Quality Assurance Specialist

Quality Assurance is responsible for gathering and collating data from the various departments of the Pharma manufacturing site and preparing for batch approval by the Qualified Person (QP).

Key Responsibilities of the Quality Assurance Specialist

The position is responsible for carrying out tasks and projects related to managing QA activities related to the site as required by GMP. These activities include change control, nonconformance investigation, raw material and batch release, quality systems auditing, and validation review activities .

Role/Opportunity:


  • Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met.Supports the development and management of GMP QA systems
  • Develop and implement processes, procedures, forms, work instructions and tools related to the implementation of quality systems at the site.
  • Assesses QA systems on ongoing basis to identify opportunities for process improvement.
  • Reviews and/or approves nonconformance investigations and their associated documentation.
  • Carries out tasks related to the management of project and site change control systems
  • Review and approval of qualification/validation documentation.
  • Carries out administration of the Supplier Assessment, Auditing and Inspection Readiness Systems at the site
  • Reviews and approves SOPs/work instructions/forms/validation plans from other departments on behalf of Quality Assurance.
  • Support QA activities for new product introductions

Skills/Experience

  • BSc essential
  • A minimum of 2 years experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry.
  • Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
  • Experience in development/and or evolution of GMP systems is desirable