CMC Regulatory Associate

CMC Regulatory Associate Our client, a global pharma company are currently recruiting for a CMC Regulatory Associate to join their team on a permanent basis.As CMC Regulatory Associateyou will lead and partner with Chemistry, Manufacturing and Controls (CMC) Regulatory Scientists in the various aspects of global marketing authorization submission management processes. You will build and manage submission content, provide guidance on structure and content placement within Common Technical Document (CTD) registration submissions, and to provide assistance with submission rel...

Location: Cork,

Partner Network Manager (Medical Devices)

Our client, headquartered in the Dublin, is an emerging medical technology company, specialising in the design and development of neuromodulation technologies to address the clinical needs of underserved patient populations, who live with chronic and debilitating tinnitus. After completing large scale clinical trials, they have started to commercialise their first product range in late 2019. In Ireland, the medical device is offered directly from our client. Customers can choose whether they want to undergo the treatment remotely (Telemedicine), in-clinic or com...

Location: Dublin,

Quality Manager (Laboratory Diagnostics)

Our client is a leading organisation in the manufacture of Laboratory Diagnostic solutions. They are currently seeking a full time, permanent Quality Manager who will report to the Director of Quality & Regulatory. This is a brand new position in the company, due to their success in developing new products. The sucessful person shall be joining an established Quality team and will be responsible for 3 direct reports. The role is based full-time on site in our clients Manufacturing facility. A senior level role suitable for someone who likes to work in a fast-paced R&D en...

Location: Limerick,

Medical Director Clinical Development Psychiatry

Medical Director Clinical Development Psychiatry Our client, a growing biotech organisation are currently recruiting for a Medical Director to join their organisation on a permanent basis. The ideal candidate will have clinical development experience in the area of psychiatry. Responsibilities Lead the execution of one or more of the organisations clinical studies and development plans while meeting standards of excellence for ethics, scientific merit and regulatory compliance. This would include Protocol design, outsourcing partner management, to results interp...

Location: Dublin, Republic of Ireland,

Senior QC Specialist

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 This job specification outlines the general responsibilities associated with the role of QC Investigations Specialist. The successful candidate will join the investigations team as a senior member of the team. Continuous Improvement with regard to investigations and error management will be key areas ...

Location: Dublin,

QC In Process Analyst - HPLC

We’re currently recruiting for an exciting opportunity with an award-winning Biopharmaceutical organization based in Cork. 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. This position is responsible for carrying out tasks and projects related to equipment, lab utilities and testing procedures as required by Good Manufacturing Practice (GMP). Partners with other Departments to ensure that all QC testing activities are completed in an efficient manner. Duties • Achieves competen...

Location: Cork,

Sales & Product Specialist (Medical, Surgical & Decontamination)

Our client is a leading distributer of Medical Capital equipment & consumables across Ireland. They are currently seeking 2 Sales & Product Specialists within their Healthcare division:one Hospital Specialist to cover the Leinster & one person in the Munster region. They require someone with a degree in business/science along with 3-5+ years Hospital Field sales experience. As these are field sales roles, the person MUST have a full, clean Irish drivers licence and an established network across the Hospitals in the relevant territory. These positions are re...

Location: Cork,

QC Scientist

We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Limerick. 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 The Scientist roles are responsible for involvement in Laboratory activities and to ensure continuous improvement in quality across the function. In addition to these duties, The Senior Scientist Chemistry role also encompasses responsibility in supporting the team Leader in the Management of lab activity...

Location: Limerick,

Senior EHS Specialist

We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Cork. 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 Assists with the design, implementation, maintenance and review of Environmental, Health, Safety and Sustainability (EHS&S) programmes to ensure compliance with regulatory, corporate and industry requirements. Acts as an SME and advisor to all teams on site in relation to EHS matters. &bu...

Location: Cork,

Senior Associate QC

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 •This job specification outlines the general responsibilities associated with the role of CW Senior Associate for the International Analytical Support function. •This role will be responsible for coordinating, facilitating, and undertaking activities pertaining to transfer of analytical met...

Location: Dublin,

Qualified Person (QP)

Qualified Person (QP) Our client a global healthcare organisation, are currently recruiting for a Qualified Person to join their team on a permanent basis. Responsibilities Perform QA/QP batch release as required to support operational business requirements (you will be required to be named on the site manufacturing licence as a QP and perform QP batch release as per current relevant EU guidelines) Provide technical expertise for all QA and compliance topics/issues as required Provide QA input into relevant Risk Management programmes within t...

Location: Galway,

Quality Engineer

We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Galway . 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 You will support the validation requirements for a product transfer to the Galway site providing input to process development and process validation. • Author and support (input and critical review) of qualification/validation protocols/reports. • Support the introduction%...

Location: Galway,

Technician II

We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Galway. 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 Support printer procurement for printing of MDR Patient Implant Card and labels • Supporting all MDR printer implementation activities. • Responsible for the installation, calibration and preventative maintenance of any printing equipment required for MDR. • Carry out set-up, trouble shoo...

Location: Galway,

Electrical Engineer (AutoCAD/Automation)

Our client is a leading manufacturer of Cleanroom solutions for the Pharma & Biopharma sectors. They are based in Kilkenny. Reporting to the Automation & Electrical Engineering Manager in the US and the Project Manager in Kilkenny, the Electrical Engineer will be involved in all AutcoCAD & automation activities including: implementation of sequences of operations, writing functional specifications (FS) and design specifications (DS), creating project software and project specific graphics, and conducting engineering testing activities, Factory Acc...

Location: Kilkenny,

Regulatory Project Manager

Regulatory Project Manager Our client, a growing biotech organisation are currently recruiting for a Regulatory Project Manager to join their organisation on a permanent basis. As Regulatory Project Manager you will be responsible for the coordination and the day-to-day support of the regulatory affairs strategy and operational activities of the organisation. As Regulatory Project Manager you will provide support to both CMC, non-clinical, and clinical development. Responsibilities Coordinate input from external regulatory affairs consultants, identify and close knowledg...

Location: Dublin,

Clinical Trial Capabilities Assistant Fluent German

Clinical Trial Capabilities Assistant Fluent German Our client, a global pharmaceutical organisation based in Cork are currently recruiting for a Clinical Trial Capabilities Assistant to join their team on a permanent basis. Fluent German and English is a requirement for this role. As Clinical Trial Capabilities Assistant you will provide technical support to the clinical trial capabilities team in support of clinical development. You will be responsible for activities related to investigator sites readiness, maintenance and close out, ensure inspection readiness through a...

Location: Cork,

Quality, Safety & Risk Manager

Quality, Safety & Risk Manager Our Dublin based client are currently recruiting for a Quality, Safety & Risk (QSR) Manager who will support the design, implementation, monitoring and review of the Quality, Safety & Risk (QSR) framework. The framework will underpin the development of a robust standardised, accredited patient safety model which underpins the delivery of efficient, effective safe services and an excellent patient experience within a financially sustainable delivery model. The role holder will play a key role in designing and i...

Location: Dublin,

Senior Quality Assurance Specialist

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 •Provide high complexity tactical support to Site Leads across multiple Quality Systems and Processes. • Manage and own NC records for External Quality • Manage and own CAPA records for External Quality • Manage and own Change Control records internal to External Quality %...

Location: Dublin,

Contract & Budgets Trial Capabilities Associate Fluent German

Contract & Budgets Trial Capabilities Associate Fluent German Our client, a global pharma company based in Cork, are currently recruiting for a Fluent German speaking Contracts and Budgets Trial Capabilities Associate to join their team on a permanent basis. As Contracts & Budgets Associate you will be responsible for overseeing specific clinical contract activities, including providing contract process guidance, conducting contract negotiations, conducting contract analyses, facilitating compliance, and pursuing contracting process improvements. ...

Location: Cork,

Customer Meeting Services Analyst Fluent Norwegian Danish or Swedish speaker

Customer Meeting Services Analyst Fluent Norwegian Danish or Swedish speaker Our client, a global pharmaceutical company are currently recruiting for a Fluent Norwegian, Danish, or Swedish speaker to join their Customer Meeting Services team on a permanent basis. The Customer Meeting Services (CMS) team supports the organisation globally with meeting planning, oversight, execution and transfer of value (TOV) data collection to enable compliance with the EFPIA Disclosure Code. Responsibilities : Be seen as a “go-to” information resource for ...

Location: Cork,

Clinical Trials Start Up Associate Fluent Polish

Clinical Trials Start Up Associate Fluent Polish Our Cork based client are currently recruiting for a Fluent Polish speaking Clinical Trials Start Up Associat

Location: Cork,

Clinical Regulatory Associate

Clinical Regulatory Associate Our client, a global pharma company are currently recruiting for a Clinical Regulatory Associate to join their team on a permane

Location: Cork,

Analytical Services Manager

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. Duties • Instrumental in developing a culture of quality and critical review across QC, Stability and Validation in compliance with Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP). • Responsibility for the dissemination of information relating to quality to the wider business. %...

Location: Tipperary,

QC Technical Specialist (LOA008304)

POSITION OVERVIEW Reporting to the Quality Control Lab, Systems and Compliance Team Leader, this position will have a significant role in the automation of analytical methods using SmartLab. This includes coordinating with the Quality Control Lab, writing SmartLab script, performing demoes, troubleshooting and verification of other Scripters work. A candidate experienced in Waters Empower administration would also be involved in the administration of same and connection of new instrumentation. QC TECHNICAL SPECIALIST RESPONSIBILITIES: Write SmartLab sc...

Location: Cork,

Associate Quality Engineer

We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Galway. 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 At our Sterilization Validation Services Department, we focus on product quality excellence and providing exemplary service to the business units we support. Our Quality Engineers are directly involved in building the organization in support of Sterility Assurance for New Product Development and Site Transfers...

Location: Galway City,

Clinical Trial Start Up Associate Fluent Romanian

Clinical Trial Start Up Associate- Fluent Romanian Our client, a global pharmaceutical organisation are currently recruiting for a Fluent Romanian speaking Clinical Trials Start Up Associate to join their team on a permanent basis. As Clinical Trial Start Up Associate you will be responsible for ensuring the investigator sites meet requirements to enrol study participants into clinical trials and support ongoing activities during site maintenance and closeout, obtaining clinical trial authorizations and ethical approvals,execution of the budget and contract, and activiti...

Location: Cork,

Sr Quality Engineer

We’re currently recruiting for an exciting opportunity with an award-winning medical Device organization based in Galway. 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 Responsibilities may include the following and other duties may be assigned. • Undertakes and successfully completes complex test method development tasks including: creation, writing, test method validation, equipment qualification and supporting on-going maintenance of test methods. • Leads ...

Location: Galway,

Snr Associate QC

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 Testing of raw materials, in process, stability and finished product samples. Eg Ph, Appearance, Colour, Clarity, Sub Visible Particle testing, Osmolality, Protein Concentration, Polysorbate, Moisture and Device testing. Review and authorisation of Lab Data Support Analyt...

Location: Dublin,

Quality Operations Senior Specialist (LOA008170)

The Role This Pharmaceutical company is looking to recruit a Quality Operations Senior Specialist, Drug Product, EMEA and Asia Pacific on a 12 month fixed-term contract (maternity cover)to provide quality and compliance oversight support to the Quality Operations management team within External Manufacturing . Key Duties and Responsibilities: Support the coordination of quality events, change control and market complaints programs in respect of Third Party Manufacturer and Alliance Partnership relationships. Actively support the Fac...

Location: Dublin,

Technology Transfer Engineer

We’re currently recruiting for an exciting opportunity with an award winning medical device organization based in Cork. 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 Represent Quality as part of a cross functional team to ensure delivery of NPI and technology projects into production with the highest level of quality, compliance, and adherence to timelines Compile and execute validation protocols for new product/processes and software. Ensure correct implementation as per sta...

Location: Cork,

Senior Validation Engineer

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 Validation oversight of External Manufacturing sites (API, DS/DP), including process, cleaning, filter and sterilization/sanitization validation activities. • Validation document author/approver • Ensure validated parameters are correctly incorporated in Master Batch Records &bul...

Location: Dublin,

QC Associate Manager (LO A007956)

Summary: Oversees the laboratory quality control testing of in-process, stability, and final drug products. Has technical responsibility for all bioanalytical aspects of QC testing. Essential Duties and Responsibilities include, but are not limited to, the following: • Coordinates with members of Manufacturing, Stability, and Business Ops to provide analytical support. • Manages QC Analysts, distributes work load, and monitors progress. • Manages product testing to ensure efficient and compliant operations. • Review...

Location: Limerick,

Senior QA Specialist

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 •Provide high complexity tactical support to Site Leads across multiple Quality Systems and Processes. • Manage and own NC records for External Quality • Manage and own CAPA records for External Quality • Manage and own Change Control records internal to External Qualit...

Location: Dublin,

Senior R&D Engineer

We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Galway. 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 Seeking an experienced engineer to focus on all stages of the product development process from concept generation through to commercializing of cutting-edge structural heart devices. This is an exciting opportunity to get involved in the rapidly growing world of Structural Heart. The role includes the fol...

Location: Galway,

Process Scientist-Process Monitoring (LOA007843)

Summary: To provide statistical support and promote the use of statistical thinking across the site. To establish, organise and maintain effective statistics and data evaluation services pertaining to process monitoring and modelling of biological drugs. Essential Duties and Responsibilities include, but are not limited to, the following: • Apply data visualization tools and implement dashboard solutions that are customer focused, to translate data into useful information for operations managers and process engineers. • Analyse data sources an...

Location: Limerick,

Clinical Trial Associate German Speaking (based in Ireland)

Clinical Trial Associate German Speaking (based in Ireland) Our Cork based client are currently recruiting for an experienced fluent German speaking Clinical Trial Associate to join their team on a permanent basis. The Clinical Trial Capabilities Team provides clinical trial capabilities in support of clinical development. As Clinical Trials Associate you will be accountable to ensure the investigator sites meet requirements to enrol study participants into clinical trials and support ongoing activities during site maintenance and closeout. You will be responsible for obtaining clini...

Location: Cork,

Process Scientist- Manufacturing Support Upstream (LOA006904)

Summary: Supports the Upstream Manufacturing Support Process Sciences Department with analysis, troubleshooting, and process validation of manufacturing bioprocesses. Essential Duties and Responsibilities may include, but are not limited to, the following: • Supports all upstream activities including raw materials and the process from vial thaw through harvest operations. • Performs scientific process investigations with relevant departments as required. • Technical and Scientific expertise in cell culture operations for daily monitor...

Location: Limerick,

Automation Engineer

We’re currently recruiting for an exciting opportunity with an award winning pharmaceutical organization based in Cork. This is an excellent position for

Location: Cork,