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
Rachel Kent
Life Science

+353 87 427 8808
[email protected]
Connect with me on
Hot Science Jobs
Product Development Engineer II
Athlone
R&D Director
Galway
Senior Maintenance Technician
Roscommon
CQV Engineer
Dublin
Quality Technician
Dublin
Business Manager (Critical Care & Me
Dublin
Senior R&D Engineer
Dublin
Project Manager
Kildare
Supply Chain Project Manager (hybrid)
Dublin
R&D Manager
Dublin
Injection Moulding Engineer
Athlone
Senior Production Supervisor
Galway City
Senior Quality Engineer
Dublin
Injection Moulding Engineer
Athlone
R&D Manager
Galway
Documentation Specialist
Louth
Principal Design Assurance Engineer
Galway
Senior R&D Engineer
Galway
R&D Engineer
Dublin
Product Specialist (Endoscopy)
Dublin
Senior Equipment Design Engineer
Dublin
Senior R&D Engineer
Galway
R&D Technician
Galway
Key Account Manager - Retail UK National
South East
Quality Specialist
Clare
Accreditation Manager
Republic of Ireland
Senior R&D Engineer
Clare
Senior Production Supervisor
Galway City
Senior Quality Engineer
Dublin
Principal R&D Engineer
Galway
Senior Reg Affairs Specialist - Post Mar
Galway
Quality Control NPI Specialist
Carlow
Quality Assurance Specialist (shift)
Carlow
Manufacturing Technician
Clare
Senior Principal R&D Engineer
Galway City
Program Manager (AVI Lines Operational R
Dublin
Senior Quality Engineer
Dublin
Senior Regulatory Affairs Specialist
Westmeath
Project Engineer
Clare
Senior Engineering Manager
Limerick
Senior Regulatory Affairs Specialist
Athlone
Quality Control Analyst (shift)
Carlow
R&D Director
Galway
Project Engineer
Roscommon
Senior NPI Engineer - Hybrid
Dublin
Senior Quality Assurance Technical Suppo
Dublin
Quality Assurance Specialist (shift)
Carlow
Senior R&D Manager - Lifecycle Manag
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Process Development - Senior Project Man
Dublin
Quality Technician
Galway
Distribution Manager (Chemicals)
Dublin
Manufacturing Technician
Clare
CTO
Dublin
Product Specialist - Orthopaedic Divisio
Dublin
R&D Engineer
Galway
Quality Engineer - Supplier
Galway
Quality Assurance Engineer
Longford
Senior Mechanical Engineer
Dublin
Commercial Attribute Science Snr Associa
Dublin
Continuous Improvement Coach
Limerick
Senior Project Engineer - R&D
Galway
Senior Equipment Design Engineer
Dublin
Director of Regulatory Affairs
Galway
Principal Software Engineer
Athlone
Product Development Engineer
Dublin
Senior Quality Engineer
Dublin
NPI Engineer - Hybrid
Dublin
R&D Engineer
Clare
Senior Electronic Engineer
Dublin
Director of R&D
Clare
R&D Manager
Athlone
Senior Manufacting Engineer
Republic of Ireland
Senior Quality Engineer
Leitrim
Quality Manager - NPI
Dublin
Senior Quality Engineer
Galway
Sterilisation Manager
Tipperary
CTO
Galway
Senior Operations Engineer
Galway
Director of R&D
Limerick
Injection Moulding Engineer
Leitrim
Industrial Designer
Galway
Senior Research Engineer
Galway
Injection Molding Engineer
North Leinster
Continuous Improvement Coach
Limerick
Sales/Customer Service Administrator
Clonmel
Bioprocess Associate
Louth
Senior R&D Engineer
Galway
Senior Design Engineer
Dublin
Product Development Engineer
Galway
Senior R&D Engineer
Dublin
Sterilisation Manager
Tipperary
Project Manager - R&D
Galway
Mechanical Engineer
Dublin
R&D Engineer
Galway
R&D Manager
Galway
R&D Manager
Connaught
Quality Assurance Associate
Cork
Maintenance & Reliability Technician
Limerick
Strategic Automation Lead
Waterford
Senior Manufacturing Engineer
Galway
Supply Chain Specialist - New Material I
Meath
Senior Equipment Engineer
Dublin
Director of Quality Engineering
Limerick
Product Development Technician II
Galway
Product Development Engineer II
Athlone
Quality Engineer
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Quality Assurance Team Lead
Cork
R&D Engineer
Galway
Quality Engineer
Galway
QA Manager
Canada
Senior Process Development Engineer
Dublin
Senior Electrical Engineer
Galway
Quality Manager
Dublin
Principal Engineer
Dublin
R&D Manager
Galway
Quality Engineer
Galway
Senior Electronic Engineer - Regulated M
Galway
Senior R&D Manager
Athlone
Senior Research Scientist
Galway
Business Development Manager
Republic of Ireland
Senior Product Development Engineer
Galway
R&D Engineer
Galway
QA Engineer
Leitrim
Quality Technician
Dublin
Senior Research & Development Engine
Limerick
Sr Principal R&D Engineer
Galway
Supplier Quality Engineer
Galway
Product Development Engineer II
Athlone
Senior Equipment Design Engineer
Dublin
R&D Engineer
Galway
R&D Manager
Athlone
Senior Regulatory Specialist
Cork
Senior R&D Engineer II
Galway
Business Development Manager (Hospitals)
Cork
Pharmacovigilance Manager (Remote)
Republic of Ireland
Manufacturing Technician
Clare
Technical Life Cycle & Engineering M
Galway
Process Chemist
Limerick
Senior Quality Engineer
Leitrim
Principal Design Assurance Engineer
Galway
Project Manager (Pharma)
Dublin
Responsible Person (RP)
Republic of Ireland
R&D Manager
Galway
Quality Assurance Team Lead
Cork
Quality Engineer
Galway
Quality Engineer
Galway
Senior Maintenance Technician
Kilkenny
Senior Product Development Engineer
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Staff R&D Engineer
Limerick
Senior Contract Development & Manufa
Dublin
R&D Engineer
Galway
Senior Project Manager - Fill Finish
Dublin
Senior Quality Assurance Associate
Dublin
Manufacturing Technician
Clare
Project Manager
Galway
Production Manager
Dublin
Senior Quality Assurance Specialist
Dublin
Senior Quality Engineer
Dublin
Reg Affairs Specialist
Connaught
Senior Principal Design and Development
Galway
Supplier Quality Engineer
Galway
Technical Life Cycle & Engineering M
Galway
R&D Engineer
Dublin
Quality Assurance Specialist/Manager
Dublin
Senior QC Associate (Bioassay)
Dublin
R&D Manager
Galway
Senior Research and Development Engineer
Galway
Quality Engineer
Athlone
Principal Design Assurance Engineer
Galway
R&D Program Manager
Dublin
Regulatory Affairs Specialist
Cork
Continuous Improvement Coach
Limerick
Manufacturing Specialist - Investigation
Dublin
Senior Process Engineer
Longford
Senior Quality Engineer
Dublin
Senior Design Assurance Engineer
Galway
Senior QA Associate (shift)
Dublin
Senior Quality Engineer
Dublin
Clinical Trial Manager
Republic of Ireland
Design Assurance Engineer
Galway
Process Engineer
Carlow
R&D Manager
Connaught
Senior Regulatory Affairs Specialist
Athlone
Principal R&D Engineer
Galway
R&D Lifecycle Manager
Connaught
Construction Manager - Pharma/Biotech
Dublin
R&D Director
Galway
Senior R&D Engineer
Galway
Validation & Verification Engineer
Dublin
R&D Manager
Connaught
Calibration Technician
Republic of Ireland
Senior Product Development Engineer
Galway
Quality Systems Manager
Dublin
R&D Manager
Connaught
Product Specialist (Critical Care &
Dublin
CQV /CSV Quality Assurance Specialist (H
Dublin
Senior Design Assurance Engineer
Galway
Sr Project Manager - Syringe Fill Engine
Dublin
Project Engineer - Senior
Cavan
Senior R&D Manager
Athlone
Advanced Technologies Manager
Galway
Senior Regulatory Affairs Specialist
Athlone
Quality Manager
Galway
Laboratory Systems Specialist
Meath
Project Manager
Kildare
Principal R&D Engineer
Galway City
Senior Electronics Engineer
Limerick
Senior Regulatory Affairs Specialist
Athlone
Change Control Specialist
Tipperary
Manufacturing Engineer
Galway
Senior Operations Engineer
Galway
Senior Design Assurance Engineer
Galway
Quality Specialist
Tipperary
Quality Engineer
Athlone
Supply Chain Specialist - New Material I
Meath
Warehouse Operator
Meath
R&D Engineer
Galway
Quality Manager
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

Senior Quality Assurance Specialist


Reference:RK5297 Location: Dublin
Qualification:DegreeExperience:5-7 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QA Specialist

Senior Quality Assurance Specialist
Remote
RK5297
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.



This role requires a strong understanding of Quality requirements associated with aseptic manufacturing, as well as an excellent understanding of C & Q / Validation and Technical Transfer requirements. The desired candidate should have a proven track record in QA leadership, and be comfortable working as part of a cross functional team.



Key Responsibilities:

  • Provide overall quality direction for processes and procedures associated with all aspects of new equipment introduction, including Computerised System Validation
  • Act as the Quality point of contact and decision-maker for C & Q / Validation execution activities, ensuring all activities comply with regulatory and company standards.
  • Lead Quality review and approval of validation documentation associated with new facilities and new product introduction
  • Lead QA review and approval of SAP BOMs, MBRs and recipes as applicable.
  • Partner cross-functionally with PD, Engineering, and Operations teams to ensure all NPI activities are compliant with regulatory and Site Quality Requirements.
  • Provide Quality Direction and input for Change Controls, CAPAs, and Deviation Investigations.
  • Support Inspection Readiness and Regulatory Audits, representing QA for Validation and NPI areas.
  • Conduct risk assessments and develop mitigation strategies for potential challenges in equipment / product introduction.
  • Provide input and Quality Oversight for change control development and implementation.
  • Ensure timely and robust implementation of change controls and CAPA records.
  • Write, review, and approve Standard Operating Procedures (SOPs) in alignment with company policies.
  • Ensure all activities align with company’s safety standards, SOPs, and regulatory expectations.
  • Support a safe working environment by adhering to all environmental health and safety practices, rules, and regulations.

Education and Experience:
  • University degree in a Science-related discipline.
  • Minimum of 7 years’ relevant experience in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Manufacturing)
  • In-depth knowledge of applicable regulatory requirements and experience with regulatory inspections.
  • Experience working in aseptic operations, relating to vial and syringe filling.
  • Understanding of principles of Validation and New Product Introduction
  • Proven experience in Quality Systems (change control, non-conformance, corrective and preventative actions)


If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.