Regional QP - Pharmaceutical
Salary: Highly competitive, plus additional benefits
Travel: Limited, around 10%
Our Client, a Global Pharmaceutical company are looking to recruit for an experienced QP / Regional QP who will work as a vital part of the Quality/ RA team and in return will be rewarded with a competitive salary plus additional benefits with expanded quality experience.
- To carry out the duties and responsibilities of a Qualified Person as detailed in EU Directive 2001/83/EC
- To ensure the principles and responsibilities of GMP / GMDP, as stated in Directive 2003/94/EC and interpreted in the EU Guide to GMP have been followed and perform the duties of the responsible person as per MHRA
- and EU regulations (2013/C 34301).
- The review of batch documentation for pharmaceutical products and subsequent batch disposition, including certification for release
- Sampling, inspection, batch processing and approval of bought-in products
- Liaison with contract laboratories and review of data generated following analysis
- Review of data generated by temperature monitoring equipment received with deliveries
- Investigations into customer complaints
- Management of recalls of pharmaceutical products for the market
- Internal and external inspection programmes and to represent the department during regulatory inspections
- Review and processing of expired inventory, returns and rejects
- Maintain communication with third party warehouse, suppliers and line management.
- MUST BE a UK registered Qualified Person (essential)
- BSc in Pharmacy or related science
- Solid experience working within Quality Assurance
- Experience of Analytical Method Transfers
- Experience of new product introductions / transfer of QP release activities
- Experience liaising with the MHRA
- Have an understanding of pharmaceutical Quality Management Systems relevant to complaints handlingand investigations
- Experience using SAP, Trackwise and Documentum