- East Midlands, England
- Pharma & Biotech
Qualified Person - Midlands - Salary Negotiable dependant on experience
Real are representing a medium sized Pharmaceutical business based in the Midlands who are looking to bring on a dynamic Qualified Person who help with their batch release alongside other daily QA duties.
You will be tasked to effectively guide and advise the Quality Assurance function to ensure that all relevant legislative requirements are met, customer requirements are met and industry best practice is constantly achieved.
You will be working alongside other QPs and have support and a direct link into the Senior Management team.
- To carry out the duties of a Qualified Person (QP) as stated in Directive 2001/83/EC for Medicinal Products for Human Use.
- Control and perform release of EU licensed, Imported licensed and bulk product, according to the duties and responsibilities outlined in the EU GMP guide, Annex 16.
- Assist and advise QC in release of Raw materials and packaging components.
- To review and approve validation documentation (equipment/process/cleaning), from all licensed product types within the remit.
- To review and approve change control documentation from all licensed product types within remit.
- Review and approve initial regulatory Marketing Authorisation Applications in the capacity of Quality Expert for Module 2. To be a member of the audit team covering Internal and Supplier Audits
- Assist in risk assessment, NCR and CAPA system documentation and investigations. Authorise documentation pertinent to the manufacture and packaging of licensed products.
- To assist with arising GMP issues within the factory and Quality Management System.
Shortlisting for this position has begun with a view to holding interviews over the next couple of weeks. For further information please contact Sarah Irvine at Real Staffing.
We also offer shopping vouchers for any successful referrals so if you know of anyone who may be suitable then please feel free to get in touch.
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales