Technical Quality Assurance Specialist
Hybrid
RK3852
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.

Duties:

• Provide quality input for processes and procedures associated with technology transfer, NPI, and product lifecycle changes.
• Act as a key Quality team member during technology transfer activities, ensuring compliance 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.
• Contribute to maintaining robust and compliant validation documentation to support site activities.
• Support risk assessments and develop recommendations to address potential challenges in process transfers.
• Provide input and quality oversight for change control development and implementation.
• Quality review and approval of Bill of Materials (BOMs), Master Batch Records (MBRs), and production recipes.
• Collaborate with cross-functional teams to support process optimization and successful scale-up to commercial manufacturing.
• Contribute to the development, review, and approval of Standard Operating Procedures (SOPs) in alignment with policies.
• Ensure all activities align with safety standards, SOPs, and regulatory expectations.
• Promote a safe working environment by adhering to environmental health and safety practices, rules, and regulations.

Education and Experience :

• University degree in a Science or Engineering-related discipline.
• Minimum of 7 years of relevant experience in the pharmaceutical or biotechnology industry.
• Experience with technical transfer and validation processes, with exposure to PPQ activities.
• Understanding of validation principles and regulatory requirements for process validation (FDA, EMA guidelines).
• Experience with change control, non-conformance resolution, and CAPA processes.

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