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
QA Manager
Canada
Principal Software Engineer
Athlone
Quality Assurance Team Lead
Cork
Responsible Person (RP)
Republic of Ireland
R&D Director
Galway
Product Specialist (Critical Care &
Dublin
Senior Regulatory Affairs Manager
Galway
Laboratory Systems Specialist
Meath
Learning Systems Lead
Limerick
R&D Engineer
Dublin
Equipment Engineer (Syringe filling)
Dublin
R&D Manager
Galway
Principal R&D Engineer
Galway
R&D Engineer
Dublin
Principal Engineer
Dublin
R&D Director
Galway
Senior NPI Engineer - Hybrid
Dublin
Biomedical Engineer
Dublin
Senior Operations Engineer
Galway
Purchasing & Planning Manager
Wexford
Process Chemist
Limerick
Design Assurance Engineer
Galway
Senior Quality Engineer
Dublin
Software Design Assurance Engineer
Dublin
Principal Engineer
Dublin
Principal Design Assurance Engineer
Galway
Quality Engineer
Athlone
Business Development Manager
Republic of Ireland
R&D Engineer
Galway
Quality Manager
Dublin
NPI Engineer - Hybrid
Dublin
Quality Manager
Galway
Senior Design Engineer
Dublin
Quality Engineer
Galway
Senior Manufacturing Engineer
Galway City
Senior R&D Engineer
Galway
Senior Design Assurance Engineer
Galway
Senior Design Engineer
Dublin
Senior R&D Engineer
Galway
Production Operator
Meath
R&D Engineer
Galway
Project Engineer
Clare
Quality Assurance Specialist
Carlow
R&D Senior Program Manager
Galway
R&D Manager
Galway
Staff R&D Engineer
Limerick
Quality Manager
Galway
Senior Design Engineer
Dublin
Senior Technician Quality Control
Carlow
R&D Manager
Athlone
R&D Engineer
Galway
Supply Chain Specialist - New Material I
Meath
R&D Engineer
Galway
Senior Quality Assurance Specialist
Cork
Injection Moulding Engineer
Leitrim
Dental- Manager/ Senior Manager Business
Republic of Ireland
Sr Electrical Engineer
Galway
Senior QC Microbiology
Dublin
Technical Transfer Specialist - Remote
Republic of Ireland
Senior R&D Engineer
Galway
Product Development Engineer
Galway
Senior Human Factors Engineer
Galway
R&D Manager
Connaught
Project Manager
Kildare
Production Manager
Dublin
CTO
Galway
Senior R&D Engineer
Galway
Supply Chain Project Manager (hybrid)
Dublin
Senior Electronic Engineer
Dublin
Key Account Manager - Retail UK National
South East
Senior Product Development Engineer
Galway
Operations Engineer
Galway
Senior Equipment Design Engineer
Dublin
Quality Specialist
Tipperary
Quality Manager
Dublin
Senior Electronics Engineer
Limerick
Senior Quality Control Associate
Dublin South
Project Manager (Pharma)
Dublin
Principal R&D Engineer
Dublin
Senior R&D Manager
Athlone
Senior Design Assurance Engineer
Athlone
Distribution Manager (Chemicals)
Dublin
Senior R&D Engineer II
Galway
Senior Operations Engineer
Galway
Director of R&D
Limerick
Reg Affairs Specialist
Connaught
Senior Regulatory Affairs Specialist
Athlone
Quality Engineer - Supplier
Galway
Senior Mechanical Engineer
Dublin
Clinical Trial Manager
Republic of Ireland
Senior Regulatory Affairs Specialist
Clare
R&D Manager
Galway
Senior R&D Engineer
Galway
Electrical Condition Monitoring Technici
Limerick
R&D Manager
Connaught
Senior R&D Manager - Lifecycle Manag
Galway
Senior Quality Assurance Technical Suppo
Dublin
Sterilisation Manager
Tipperary
R&D Manager
Connaught
Senior Quality Engineer
Dublin
Purchasing & Planning Manager
Wexford
Quality Technician
Galway
Senior Maintenance Technician
Kilkenny
Quality Engineer
Athlone
QA Operations Specialist
Dublin
Warehouse Operator
Dublin
Senior Manufacturing Specialist
Dublin
Senior Maintenance Technician
Kilkenny
Senior Research & Development Engine
Limerick
R&D Manager
Galway
Quality Assurance Associate
Cork
Senior R&D Engineer
Galway
R&D Manager
Dublin
R&D Engineer
Galway
Product Development Manager
Galway
Senior R&D Engineer
Galway
Quality Assurance Specialist/Manager
Dublin
Quality Control NPI Specialist
Carlow
Application Software Engineer
Galway
R&D Manager
Galway
Facilities Engineer
Wexford
Injection Moulding Engineer
Athlone
Product Specialist - Orthopaedic Divisio
Dublin
Senior Manufacting Engineer
Republic of Ireland
Design Assurance Manager
Galway
R&D Engineer
Galway
QA Engineer
Leitrim
Quality Assurance Specialist (hybrid)
Dublin
Continuous Improvement Coach
Limerick
Senior Quality Engineer
Dublin
Process Development Engineer
Galway
Quality Engineer
Athlone
Pharmacovigilance Manager (Remote)
Republic of Ireland
QC Bioanalytical Sciences - Senior Assoc
Dublin
Program Manager (AVI Lines Operational R
Dublin
Continuous Improvement Coach
Limerick
Senior Engineering Manager
Limerick
R&D Director
Galway
Quality Assurance Senior Specialist
Louth
Senior Equipment Engineer
Dublin
Maintenance & Reliability Technician
Limerick
Principal Process Equipment Engineer
Dublin South
R&D Manager
Connaught
Manufacturing Specialist - Investigation
Dublin
Senior R&D Engineer
Galway
Quality Engineer
Galway
Senior R&D Engineer
Dublin
Process Engineer
Leitrim
Senior R&D Engineer
Galway
Maintenance & Reliability Technician
Limerick
Senior R&D Engineer
Galway
Commercial Attribute Science Snr Associa
Dublin
Quality Specialist
Clare
Quality Assurance Specialist (shift)
Carlow
Mechanical Engineer
Dublin
Embedded Software Engineer
Dublin
Quality Engineer
Galway
Business Development Manager (Hospitals)
Cork
Quality Assurance Engineer
Longford
Senior Production Supervisor
Galway City
Senior Equipment Design Engineer
Dublin
Product Development Engineer
Dublin
Senior Product Development Engineer
Galway
Injection Moulding Engineer
Athlone
Senior Regulatory Affairs Specialist
Athlone
Quality Assurance Specialist (Hybrid)
Dublin
Documentation Specialist
Louth
Senior R&D Engineer
Galway
Injection Moulding Engineer
Athlone
Commercial Solutions Manager (Medical De
Dublin
Industrial Designer
Galway
Quality Engineer - Supplier
Galway
Calibration Technician
Republic of Ireland
Key Account Manager (Retail & Pharm
Dublin
Product Development Engineer
Dublin
Quality Engineer
Galway
Principal R&D Engineer
Galway City
Continuous Improvement Coach
Limerick
Biomedical Engineer
Dublin
R&D Technician II
Galway
Manufacturing Engineer
Galway
Project Manager - New Product Introducti
Dublin
Senior Principal R&D Engineer
Galway City
Warehouse Operator
Meath
Sr Principal R&D Engineer
Galway
Senior Design Assurance Engineer
Galway
Quality Technician
Dublin
Senior Quality Engineer
Leitrim
R&D Manager
Athlone
Project Manager
Kildare
Graduate Occupational Hygiene Consultant
Kildare
CQV /CSV Quality Assurance Specialist (H
Dublin
Principal R&D Engineer
Galway
Microbiology Manager
Dublin
Senior Quality Engineer
Dublin
Warehouse Operator
Meath
Manufacturing Technician
Clare
Senior Production Supervisor
Galway City
Senior Quality Engineer
Dublin
Principal R&D Engineer
Galway
Manufacturing Technician
Clare
Health & Safety Specialist
Dublin
Business Manager (Critical Care & Me
Dublin
Quality Specialist
Dublin
Senior Associate Quality Control (Shift)
Dublin
R&D Engineer
Galway
R&D Director
Galway
Senior Electronic Engineer - Regulated M
Galway
Senior Design Assurance Engineer
Galway
Quality Engineer
Galway
Senior Project Engineer - R&D
Galway
Equipment Engineer (Formulation, Autocla
Dublin
R&D Engineer
Clare
Regulatory Affairs Maanger
Galway
Senior R&D Engineer
Galway
Senior Regulatroy Affairs Specialsit
Galway
CTO
Dublin
Regulatory Affairs Manager- Remote
Republic of Ireland
Accreditation Manager
Republic of Ireland
Senior Research Engineer
Galway
Director of Quality Engineering
Limerick
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.