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CQV /CSV Quality Assurance Specialist (Hybrid)
| Reference: | RK5149 | Location: |
Dublin |
| Qualification: | Degree | Experience: | 5-7 Years |
| Job Type: | Fixed Term Contract | Salary: | Not Disclosed |
CQV / CSVQuality 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
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