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6 days ago
We are seeking a Quality Assurance Specialist to join our team at Collins McNicholas. The ideal candidate will have a third-level qualification in a science discipline and 5 years' experience in the pharmaceutical industry.
Key Responsibilities- Comply with EU guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Annex 16: Certification by a Qualified Person and Batch Release; Article 47 of Directive 2001/83/EC.
- Ensure that products manufactured at our facility are manufactured in accordance with relevant GMPs.
- Disposition bulk product as acceptable for release, or reject, to ensure patient safety based on the information available relating to the manufacture and testing of the batch.
- Third level qualification in a science discipline with 5 years' experience in the pharmaceutical industry.
- MSC in Industrial Pharmaceutical Science or similar course recognized by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC
- 5 years industrial experience gained in an FDA and EMEA approved pharmaceutical environment.
- 2 Years' experience gained within an aseptic processing environment, ideally gained within a quality function.
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