Qualified Person - London
CK Group is recruiting for a Qualified Person to join a global company in the pharmaceutical industry at their site based in Brentford on initially a 9-12 month contract.
The Company: Our client is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to create a platform for the delivery of strong growth in a rapidly changing healthcare market. Their mission is to improve the quality of human life by enabling people to do more, feel better and live longer.
The Location: Brentford is located at the confluence of the rivers Brent and Thames. The area is well severed by public transport from central London, Waterloo station and surrounding areas.
Job Details: Responsible for the Quality oversight of the supply of consumer products from manufacturing sites into the UK and Ireland warehouses. The portfolio of products includes medicines, medical devices and cosmetics. For medicines, this specifically includes performing duties and obligations of QP in accordance with Annex 16, cGMP Requirements and Directive 2001/83/EC for the UK
- Lead batch assessment and release activities to ensure releases are carried out efficiently, in a timely manner, and meeting relevant regulatory standards. Perform QP certification and associated placement on the market through the CERPs system for UK market.
- Accountable for review and approval of Quality Agreements and liaison with manufacturing sites to ensure compliance to local registered technical details (in connection with local regulatory team), including Distribution Risk Assessments for products supplied from manufacturing site to market.
- Liaison with Contract Manufacturer Organisation (CMO) Quality for products that are manufactured by contractors to ensure compliance to local registered technical details (in connection with local regulatory team).
- Investigate and resolve Quality-related issues arising from the deliveries with Area Quality Lead, Logistic Services Provider (LSPs) and supplying sites.
- Manage temperature excursions from deliveries from supplying sites to local UK warehouse.
- Perform all quality activities into CERPS and GMM as appropriate.
- Provide oversight on positive release process for cosmetic products with the local warehouse and manufacturing site as necessary.
- Provide oversight on local Repacking.
- Support relevant quality processes including deviations, CAPA, Self Inspection, Change Control, Management.
- The person must be a Qualified Person with relevant experience as covered by Directive 2001/83/EC relating to medicinal products for human use.
- 3+ years working as a QP.
For more information or to apply for this position, please contact Heather or the 180 Team on 0191 3848905 or email email@example.com. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45803 in all correspondence.