Technical Quality Assurance Specialist Hybrid RK3852 12 Months Dublin Were 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.
Skills: Quality Assurance GMP Technical Transfer