Responsibilities:
Provide QA oversight for Qualification and Validation activities of the site's production, testing and storage facilities with the following core responsibilities:
- Support all aspects (i.e. development, execution and maintenance) of the site's qualification and validation program, covering but not limited to: facility, utilities, process and analytical testing equipment, manufacturing process, analytical methods, GMP computerized systems and product & material shipping routes.
- Provide quality oversight for validation-related cGMP documents including but not limited to: validation plans, SOPs and forms, IQ/OQ/PQ protocols, summary reports; ensuring consistency and compliance with regulatory requirements.
- Provide QA expertise to assess impact and support variation / deviation investigations, CAPAs and change controls related to validation matters.
- Ensure audit readiness and provide support as needed in client audits and health authority inspections.
- Lead & support continuous improvement efforts through the evaluation of trends, audit and stakeholder feedback, or WBS projects.
- Any other duties assigned by supervisor.
Requirements:
- Bachelor's degree or higher in Life Sciences, Pharmacy, Microbiology, Biotechnology, Engineering or a related scientific discipline.
- Min. 5 years of proven Quality Assurance / Management or Validation experience in regulated pharmaceutical or aseptic manufacturing environment;
- Direct or QA oversight experience across the various validation activities i.e. from initial planning stage up to the eventual summary report generation / review, in areas as Facility, Utilities and Equipment (FUE) qualification, process / method validation, cleaning validation, computerized systems validation and shipping validation, etc.
- Comprehensive understanding of pharmaceutical quality systems and facility & equipment systems lifecycle management principles.
- Strong working knowledge of cGMP requirements and applicable regulations and guidance e.g. Title 21 of US CFR, EU GMP, ICH Quality Guidelines, PIC/S GMP Guide, ASTM E2500 and ISPE GAMP 5, etc.
- Experience performing formal risk assessments (e.g. FMEA, HACCP) and applying risk-based decision making.
- Strong analytical and problem-solving skills, with the ability to troubleshoot and manage corrective actions.
- Demonstrated ability to collaborate effectively in cross-functional team environments.
- Experience in people leadership or management is highly advantageous.
- Relevant certification e.g. Certified Quality Auditor is a plus.
