- Batch Record Review & material release to ensure compliance with GMP requirements.
- Review & Approval of Event, Deviations, and Customer complaints.
- Supports all validation activities on site as described in the Site Validation Master Plan
- Carries out tasks related to the administration of site supplier approval process.
- Co-ordinates and assists in the preparation for regulatory and customer GMP inspections of the site
- Experience as Quality Assurance Specialist in QA Operations, 3-5 years experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry.
- Bachelor's degree in a scientific/technical discipline required
- Experience in auditing of external suppliers, contractors, and vendors
