Technical Quality Assurance Specialist Hybrid
This is an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin.
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.
Skills:
* Quality Assurance GMP Technical Transfer