Swindon, United Kingdom
up to £1000,000
4 months ago
My client, based in Wiltshire are looking for Lead QP to join a fast growing business with 4 sites across the UK and still expanding. Its a great opportunity for someone with energy and passion to join a business at senior level and have real influence and input in strategy.
A great chance to be involved with a business that deals with clinical and commercial release and to be involved with business development.
Title: Lead QP
• To review batch manufacturing documentation to ensure compliance with EU GMP and the Product Specification File/marketing authorisation (or other where relevant)
• To certify Medicinal products for use in the EU and outside the EU (where relevant)
• To undertake audits in EU and third countries to ensure that sponsor manufacturing sites are operating in general compliance with EU GMP
• To provide advice and guidance to staff and customers regarding pharma regulations.
• To provide technical and quality input to projects related to products, facilities and equipment.
• To keep up to date with the requirements of the Medicines Authorities across the EU and rest of the world (where relevant).
• To review company project files (PSFs, commercial project files etc) to ensure compliance with the current regulatory requirements and company procedures.
• To provide input and assistance with relevant elements of the Quality management System within the business.
• To provide assistance with regulatory inspections and client audits.
NOT OF INTEREST TO YOU BUT KNOW SOMEONE IT WOULD BE?
Catalyst Life Sciences offer a generous referral scheme reward, whereby anyone who refers us to a successfully placed candidate is entitled to up to £250 worth of vouchers.