The Qualified Person is responsible to ensure that licensed Finished Product to include Drug Substance, Drug Product is certified and released to market by a Qualified Person named on the commercial manufacturing license in accordance with EU directive 2001/83/EC, 2004/94/EC and in accordance with the requirements of Annex 16.
To ensure that investigational medicinal product (IMP) is certified and released to sponsor by a Qualified Person named on the IMP Manufacturing License in accordance with EU directive 2001/20/EC and in accordance with the requirements of Annex 16 and Annex 13.
- QP release of pharmaceutical products across the client’s network and contract manufacturing operations to ensure commercial and clinical drug substance, drug product and finished products are certified in accordance with GMP and MA/IMPD to support patient supply for rare diseases
- QP Partner with Finished Product Operations team for on time release
- Ensure independence of the QP on decisions on quality related matters.
- Coordinate cross functionally across the business to create a culture that demonstrates excellence in quality, compliance, and continuous improvements.
- Provide quality and compliance guidance on all critical and major quality matters managed by client.
- Perform QP quality review and approval for Annual Product Quality Review
- Provide Quality oversight, input into quality documents e.g., QAGs, customer complaints as required
- Create an environment for ‘right first time’ in focusing on principles of lean, visual management and building in efficiencies as necessary from a systematic and compliance perspective
- Support Regulatory Inspections and be a representative of client in front of Health Authorities and Regulatory Bodies
- Provide audit support as required for internal auditing program and supplier audits.
- Provide support to Regulatory for Regulatory submissions (IMPD, MAA) / QP declarations and License updates.
- Maintain an up-to -date knowledge of pharmaceutical legislation and industry practice
- 8+ years GMP related experience in biopharmaceutical / pharmaceuticals.
- Demonstrated ability to act as Qualified Person within EC/EEA.
- 2+ years QP experience preferable
- Must have excellent communication skills, including excellent written, interpersonal, collaboration, and negotiation skills, with a team oriented approach.
- Extensive pharmaceutical quality experience.
- Must have thorough knowledge of biopharmaceutical manufacturing, packaging, testing, and distribution processes and associated global regulatory GMP/GDP requirements.
- Must have demonstrated understanding of the processes and interactions essential for ensuring and maintaining regulatory compliance.
Milestone Solutions is a dedicated consultancy providing industry solutions to the Life Sciences, Discrete Manufacturing, FMCG and Chemical Processing industries; for more information go to www.mile.ie