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.
 Google Chrome |
 Internet Explorer |
 Mozilla Firefox |
 Opera |
Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Print this job
Send Job Spec
Share on LinkedIn
Share on Facebook
Share on Twitter
Limerick
Kilkenny
Athlone
Dublin
Athlone
Dublin
Dublin
Dublin
Athlone
Clare
Connaught
Athlone
Westmeath
Dublin
Galway
Galway
Galway
Dublin
Dublin
Galway
Republic of Ireland
Athlone
Athlone
North Leinster
Dublin
Galway
Dublin
Limerick
Dublin
Galway
Dublin
Meath
Galway
Limerick
Tipperary
Dublin
Dublin
Galway
Longford
Dublin
Kildare
Galway
Cavan
Meath
Galway
Galway
Limerick City
Galway
Galway
Limerick
Galway
Galway
Dublin
Galway
Westmeath
Dublin
Galway
Limerick
Galway
Dublin
Galway
Wexford
Galway
North Leinster
Dublin
Galway
Limerick
Galway
Galway
Waterford
Republic of Ireland
Clare
Dublin
Galway
Dublin
Galway
Louth
Athlone
Dublin
Dublin
Connaught
Galway
Limerick
Republic of Ireland
Galway
Limerick
Galway
Galway
Dublin
Athlone
North Leinster
Connaught
Wexford
Dublin
Dublin
Galway
Dublin
Dublin
Dublin
Clare
Galway
Republic of Ireland
Dublin
Galway
Kildare
Galway
Clare
Dublin
Carlow
Dublin
Dublin
Galway
Dublin
Athlone
Tipperary
Galway
Clare
Galway
Galway
Galway
Dublin
Galway
Galway
Athlone
Galway
Galway
Galway
Dublin
Leitrim
Clare
Clare
Clare
Leitrim
Galway
Athlone
Roscommon
Dublin
Galway
Galway
Longford
Dublin
Dublin
Athlone
Galway
Dublin
Dublin
Dublin
Clare
Galway
Galway
Galway
Limerick
North Leinster
Kilkenny
Dublin
Galway
Galway
Dublin
Galway
Galway
Galway
Galway
Dublin
Clare
Republic of Ireland
Dublin
Dublin
Wexford
Republic of Ireland
Galway
Galway
Louth
Galway
Tipperary
Leitrim
Dublin
Cork
Galway
Leitrim
Dublin
Dublin South
Galway
Galway
Dublin
Galway
Galway
Galway
Tipperary
Galway
Dublin
Galway
Galway
Carlow
Connaught
Galway
Clare
Galway
Dublin
Dublin
Dublin
Galway
Galway
Dublin
Republic of Ireland
Galway
Dublin
Galway
Galway
Leitrim
Galway
Galway
Galway
Dublin
Dublin
Roscommon
Dublin
Clare
Dublin South
Galway City
Athlone
Galway
Galway
Dublin
Dublin
Galway
Republic of Ireland
Galway
Limerick
Galway
Galway
Dublin
Galway
Dublin
Connaught
Galway
Galway
Athlone
Galway
Galway
Galway
Galway
Republic of Ireland
Clare
Dublin
Wexford
Dublin
Dublin
Kilkenny
Galway
Limerick
Athlone
Galway
Leitrim
Galway
Republic of Ireland
Canada
Dublin
Limerick
Tipperary
Galway
Galway
Louth
Dublin
Meath
Meath
Carlow
Dublin
Galway City
Galway
Connaught
Galway
Galway
Galway
Galway
Dublin
Galway
Leitrim
Galway
Dublin
Galway
Galway
Dublin
Louth
Galway
Dublin
Galway
Limerick
Dublin
Republic of Ireland
Cavan
Galway
Galway
Galway
Dublin
Galway
Athlone
Dublin
Dublin
Galway
Limerick
Carlow
Louth
Limerick
Clare
Galway
Quality Assurance Specialist (Hybrid)
| Reference: | RK5149 | Location: |
Dublin |
| Qualification: | Degree | Experience: | 5-7 Years |
| Job Type: | Fixed Term Contract | Salary: | Not Disclosed |
Quality Assurance Specialist (Hybrid)
RK5149
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 policies.
• Ensure all activities align with 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
• 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
If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.
Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
Valid XHTML - CSS
