Overview of your responsibilities:
- Ensure NPI and commercial products meet applicable GMP requirements.
- Own and oversee NPI product transfers into commercial manufacturing.
- Manage Site QPs and MQA, including batch release, product performance and regulatory support.
- Ensure sterile and aseptic products meet company, customer and regulatory requirements.
- Verify batch manufacture complies with approved marketing authorisations.
- Ensure manufacturing and testing comply with GMP, including EU GMP Annex 1 and FDA requirements.
- Ensure manufacturing and testing processes are appropriately validated.
- Ensure deviations and changes are reviewed, approved and managed in accordance with established procedures.
- Ensure regulatory authorities approve changes requiring marketing or manufacturing authorisation updates.
- Maintain current knowledge of relevant technical, scientific and quality requirements.
- Science degree + pharma/healthcare experience.
- MSc in Industrial Pharmaceutical Science or equivalent, supporting QP eligibility under Article 49 of Directive 2001/83/EC.
- Experience in FDA- and EMA-regulated environments.
- Supervisory/management experience in pharma, biotech or medical device manufacturing.
- Experience in drug product manufacturing, including aseptic filling, visual inspection, solution preparation and sterilisation.
- Strong audit management and regulatory engagement experience.
courtney.russell@collinsmcnicholas.ie
+353 (0) 71 9108062
