I'm currently looking for a Quality Specialist to join a leading Global Pharmaceutical business based in the Essex area. As the Quality Specialist you will be responsible for liaising and managing global CMO's, being their main point of contact. You will also be responsible for the following:
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Quality Specialist will be varied however the key duties and responsibilities are as follows:
Liaise and work closely with Global CMO's to resolve quality issues; managing batch release processes globally.
Create and implement QTA's (Quality Technical Agreements) with the Marketing Authorisation Holders, ensuring the correct and most efficient agreements are in place to reduce issues and its CMO organisations are prepared, agreed and followed.
Managing change controls across new CMO providers. To Provide Technical advice and support on manufacturing issues related to existing products and potential products.
Liaise globally with Commercial Business Partners, working across multiple different QA teams, providing technical advice, advising on issues related to existing and potential products.
To be successful in your application to this exciting opportunity as the Quality Specialist we are looking to identify the following on your profile and past history:
1. Proven Pharmaceutical industry experience working directly with CMO's.
2. A working knowledge and practical experience of GMP regulations.
3. Experienced writing Quality Technical Agreements (QTA's)
Key Words: Quality, QTA, Quality Agreement, GMP, Pharmaceutical, CMO's
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.