Senior Quality Assurance Specialist
Hybrid
RK3853
24 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.


Duties:

• Provide overall quality direction for processes and procedures associated with technology transfer, NPI, and product lifecycle changes.
• Act as the Quality point of contact and decision-maker during technology transfer and PPQ execution activities, ensuring all activities comply with regulatory and company standards.
• Quality review and approval of validation documentation, including:
• Design Specifications (DS), User Requirements Specifications (URS), and Quality Risk Assessments (QRAES).
• Validation Plans, Protocols (IQ, OQ, PQ), and associated reports.
• Ensure robust and compliant validation documentation to support site activities.
• Conduct risk assessments and develop mitigation strategies for potential challenges in process transfers.
• Provide input and quality oversight for change control development and implementation.
• Ensure timely and robust implementation of change controls and CAPA records.
• Quality review and approval of Bill of Materials (BOMs), Master Batch Records (MBRs), and production recipes.
• Collaborate with cross-functional teams to optimize processes and ensure successful scale-up and commercial manufacturing.
• 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 or Engineering-related discipline.
• Minimum of 10 years of relevant experience in the pharmaceutical or biotechnology industry.
• Proven expertise in technical transfer, PPQ execution, and lifecycle management.
• Strong understanding of validation principles and regulatory requirements for process validation (FDA, EMA guidelines).
• Experience with change control, non-conformance resolution, and CAPA implementation.


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