I'm looking for...
close

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

crome
Google Chrome		 IE
Internet Explorer		 firefox
Mozilla Firefox		 opera
Opera

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Job Tools
Contact Info
Avishek Singh
Life Science

00353872827991
[email protected]
Connect with me on
Hot Science Jobs
Principal R&D Engineer
Galway
Strategic Automation Lead
Waterford
Biostatistician
Dublin
R&D Director
Galway
Business Manager (Woundcare, Orthopaedic
Dublin
R&D Engineer
Galway
Quality Manager - Medical Devices
Limerick City
R&D Engineer
Galway
Senior Electronic Engineer
Dublin
Senior Design Engineer
Dublin
Project Manager
Kildare
Senior Operations Engineer
Galway
Design Assurance Program Manager
Galway
Senior Design Assurance Engineer
Galway
Project Manager - R&D
Galway
Project Manager (hybrid)
Dublin
Senior Regulatory Specialist
Cork
R&D Engineer
Galway
Project Manager Design Assurance
Galway
Quality Assurance Specialist (hybrid)
Dublin
Purchasing & Planning Manager
Wexford
Senior Regulatory Affairs Specialist
Athlone
CTO
Dublin
Product Development Engineer
Dublin
Documentation Specialist
Louth
R&D Manager
Connaught
Engineering Shift Technician
Dublin
Project Manager
Kildare
Product Development Engineer
Dublin
Research & Develpment Manager
Galway
Product Development Engineer
Dublin
Electronic Engineer
Dublin
Injection Molding Engineer
North Leinster
Senior Regulatory Affairs Specialist
Dublin
Senior Equipment Design Engineer
Dublin
Senior Quality Assurance Specialist (hyb
Dublin
Senior Process Engineer
Carlow
Quality Assurance Specialist (Logistics)
Dublin
R&D Manager
Connaught
Manufacturing Technician
Galway
R&D Manager
Connaught
Application Software Engineer
Galway
Quality Manager
Dublin
Validation Engineer
Athlone
Principal Software Engineer
Athlone
Senior Equipment Design Engineer
Dublin
Injection Molding Engineer
North Leinster
Calibration Technician
Republic of Ireland
R&D Manager
Athlone
Project Manager - R&D
Galway
Regulatory Affairs Maanger
Galway
Quality Manager
Dublin
Senior R&D Engineer
Clare
Injection Molding Engineer
North Leinster
Clinical Research Associate
Cork
Sr Electrical Engineer
Galway
Sales/Customer Service Administrator
Clonmel
Maintenance Reliability Engineer
Cork
Senior Quality Control Associate
Dublin South
Sourcing Specialist
Tipperary
Senior Quality Engineer
Dublin
Senior Technical Transfer Specialist
Cork
R&D Program Manager
Dublin
Senior R&D Engineer
Galway
Senior Project Engineer
Cavan
MS&T Bioprocess Engineer
Meath
Sr Electrical Engineer
Galway
Sr Electrical Engineer
Galway
Senior Engineering Manager
Limerick
Electronic Engineer
Dublin
Principal Engineer
Dublin
R&D Engineer
Galway
Senior Equipment Engineer
Dublin
Senior R&D Engineer
Galway
Electrical Technician
Limerick
Senior R&D Engineer
Galway
Senior Product Development Engineer
Galway
Software Design Assurance Engineer
Dublin
R&D Director
Galway
Senior Quality Systems Engineer
Galway
Senior Research and Development Engineer
Galway
Senior R&D Engineer
Dublin
R&D Manager
Galway
Analytical Scientist
Meath
R&D Engineer
Galway
Senior Regulatroy Affairs Specialsit
Galway
R&D Engineer
Dublin
Senior R&D Engineer
Galway
Quality Assurance Engineer
Longford
Product Development Engineer
Dublin
Quality Engineer
Galway
R&D Manager
Athlone
Project Engineer
Limerick
Design Assurance Engineer
Clare
Senior QA CSQ/CQV Specialist
Republic of Ireland
Senior Electronic Engineer - Regulated M
Galway
Quality Systems Manager
Dublin
Senior Design Assurance Engineer
Galway
Manufacturing Engineer
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Electrical Condition Monitoring Technici
Limerick
Project Engineer
Roscommon
Process Chemist
Limerick
Manufacturing Engineer
Cork
QA Engineer
Leitrim
MS&T Scientist - AKTA systems
Meath
Injection Molding Engineer
North Leinster
Principal Process Equipment Engineer
Dublin South
Principal R&D Engineer
Galway
Senior R&D Engineer
Galway
R&D Manager
Galway
Senior Recruitment Consultant
Dublin
Staff Systems Engineer
Limerick
Pharmacovigilance Manager (Remote)
Republic of Ireland
Maintenance & Reliability Technician
Limerick
R&D Engineer
Galway
Manufacturing Engineer
Wexford
Senior R&D Engineer
Galway
Cleaning Validation Specialist
Cork
Value Stream Team Leader / Production Su
Wexford
R&D Senior Program Manager
Galway
Product Development Engineer
Dublin
Quality Assurance Senior Specialist
Louth
Principal Device Engineer
Dublin
Principal R&D Engineer
Galway
Senior Quality Engineer
Dublin
Principal R&D Engineer
Dublin
Injection Moulding Engineer
Athlone
Project Engineer
Cork
Product Development Engineer
Galway
Senior Quality Engineer
Dublin
Maintenance CMMS Engineer
Tipperary
R&D Engineer
Clare
Lead Maintenance Technician
Kilkenny
Project Manager - R&D
Galway
DeltaV Lead Automation Engineer
Tipperary
Maintenance Technician
Kilkenny
Senior Maintenance Technician
Kilkenny
Senior Manufacting Engineer
Republic of Ireland
Documentation Specialist
Louth
Senior Operations Engineer
Galway
Senior Equipment Design Engineer
Dublin
R&D Engineer
Galway
Senior R&D Engineer
Dublin
Technical Life Cycle & Engineering M
Galway
Senior R&D Engineer - Sustaining
Galway
Clinical Research Associate
Cork
Senior R&D Engineer
Galway
Lead Maintenance Technician
Kilkenny
Sr R&D Manager
Galway
Senior R&D Engineer
Galway
Senior Process Engineer
Galway
Quality Engineer
Galway
Senior Tech Transfer Specialist
Meath
Technical Life Cycle & Engineering M
Galway
R&D Manager
Galway
R&D Engineer
Galway
Senior Associate Quality Control (Shift)
Dublin
Cleaning Validation Specialist
Cork
Clinical Research Manager
Cork
Senior Regulatory Specialist
Cork
Director Engineering & Supply Chain
Galway
Senior Quality Assurance Specialist (Shi
Dublin
Senior R&D Engineer
Galway
R&D Manager
Dublin
Documentation Specialist
Louth
Senior R&D Engineer
Galway
QA Manager
Canada
Senior Principal Design and Development
Galway
Design Assurance Engineer
Clare
Purchasing & Planning Manager
Wexford
Senior Maintenance Technician
Kilkenny
Sr R&D Manager
Galway
Senior QC Associate
Dublin
Responsible Person (RP)
Republic of Ireland
Senior R&D Engineer-New Product Deve
Westmeath
Manufacturing Engineer
Galway
Quality Manager
Galway
Senior R&D Engineer
Clare
Reg Affairs Specialist
Connaught
Senior Process Development Engineer
Galway
National Sales Manager
Dublin
Principal Research and Development Engin
Galway
Senior Regulatory Affairs Specialist
Westmeath
Senior Quality Engineer
Leitrim
Manufacturing Technician
Clare
Senior Associate Quality Control
Dublin
Principal Quality Engineer
Galway
Lead Chemistry Analyst
Cork
Quality Specialist
Tipperary
Electronic Engineer
Dublin
Senior Regulatory Affairs Specialist
Athlone
Manufacturing Technician
Clare
R&D Engineer
Galway
R&D Manager
Connaught
R&D Engineer
Dublin
Site Microbiologist
Republic of Ireland
Senior R&D Engineer
Galway
Biomedical Engineer
Dublin
R&D Engineer
Galway
Quality Technician
Dublin
Principal R&D Engineer
Galway
Senior Product Development Engineer
Galway
Quality Specialist
Clare
Materials Controller (Biopharma - Limeri
Limerick
Quality Assurance Team Lead
Cork
Advanced Technologies R&D Manager
Clare
Senior Quality Engineer
Leitrim
Quality Assurance Team Lead
Cork
Technical Marketing Manager
Wexford
Quality Specialist
Clare
E&I Turnover Engineer
Carlow
Project Engineer - Senior
Cavan
Change Control SME
Cork
Senior Electronic Engineer
Dublin
Regulatory Affairs Specialist
Cork
Manufacturing Technician
Clare
R&D Technician II
Galway
CTO
Galway
R&D Manager
Galway
Process Engineer
Galway
Quality Manager
Galway
R&D Director
Galway
R&D Manager
Galway
R&D Director
Galway
Senior R&D Engineer
Galway
Principal R&D Engineer
Galway
Quality Engineer
Galway
Design Quality Engineer
Galway
Learning Systems Lead
Limerick
Senior Recruitment Consultant
Republic of Ireland
Senior Recruitment Consultant
Republic of Ireland
Senior Electronic Engineer
Dublin
Senior R&D Engineer
Dublin
Process Engineer
Roscommon
Product Development Engineer
Galway
Apply for this job

Name:

Surname:

Email:

Phone:

Cv:

Salary Expectations:

Education:

Experience:

Current Location:

Notice Period:

Write here your cover note:


If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box

If you are having difficulty you can always email your cv to [email protected]
Details

Quality Assurance Senior Specialist


Reference:AS23875 Location: Louth
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QA Analyst

We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dundalk. 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 role is responsible for oversight of all validation activities ensuring compliance with current regulatory requirements, cGMP and company SOPs. It includes validation/qualification activities for facilities, utilities, equipment, computerized systems, cleaning, processes, storage areas, controlled temperature units (CTUs) and shipping. An important aspect of this role is provision of QA oversight to the Commissioning, Qualification and Validation (CQV) activities associated with the facility’s start-up project and supporting the transition from project phase through to sustaining phase with respect to validation activities.

Duties:

  • Ensure the quality oversight of the qualification/validation activities of all facilities, utilities, equipment, computerized systems, cleaning processes, manufacturing processes, storage areas, controlled temperature units (CTUs) and shipping processes.
  • Ensure that all validation documentation and associated data, including but not limited to; plans, URSs, quality risk assessments, protocols, and reports, are reviewed and approved by QA for conformance to SOPs, specifications and other applicable acceptance criteria.
  • Ensure that all events/deviations, investigations, and change evaluations that occur during qualification/validation activities have appropriate QA oversight, QA review and approval and adhere to SOPs and cGMP requirements.
  • Review SOPs relating to qualification/validation activities.
  • Provision of support in Regulatory inspections and Client audits.
  • Provision of QA Validations expertise to maintain validation status of the facility.
  • Maintain an understanding of cGMP regulations and guidance in relation to all aspects of validation and/or qualification of facilities, utilities, equipment, computerized systems, cleaning processes, manufacturing processes, storage areas, controlled temperature units (CTUs) and shipping processes.
  • Coordinate all QA Validations activities to ensure schedule adherence and on time delivery of project deliverables.
  • Manage and develop the QA Validations team including, but not limited to, activities such as performance management, recruitment, and training.
  • Other quality activities as needed and assigned.
Education and Experience:
  • B.Sc or B.Eng in a Scientific or Engineering related discipline (e.g. biochemistry, chemistry, engineering).
  • 3+ years of experience in a Quality Engineering/Quality Assurance/Quality Validations role for Biologics or related pharmaceutical/ medical device manufacturing in a FDA/ EU regulated environment.
  • Thorough understanding of the validation requirements associated with a cGMP manufacturing facility.
  • Strong technical aptitude is required.
  • Deep knowledge of GxP regulations applicable to biologics manufacturing (e.g. EU-GMP, FDA, ISO) and the industry standards applicable to validation, including but not limited to; GAMP, ISPE, ISO, ASME and BPE.
  • Knowledge of trouble shooting and problem-solving skills. Knowledge of formal root cause analysis methods and tools such as Ishikawa diagrams, FMEA etc.
If interested in this posting please feel free to contact Avishek Singh at [email protected] or 0872827991 for further information.