Senior Quality Assurance Specialist Hybrid RK3853 24 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 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.
Skills: Quality Assurance GMP Technical Transfer