Quality Controller

The role

This Quality Controller role offers a permanent full-time opportunity within a Mayfair, London based cell manufacturing operation. The successful candidate will be responsible for quality assurance and control activities, including signing off the release of finished products under an MHRA Specials licence. This position is ideal for professionals with experience in sterile or aseptic ATMP environments.

Responsibilities

• Manage quality assurance and quality control activities in a cell based manufacturing environment
• Sign off the release of finished products in accordance with MHRA requirements for MS licences
• Prepare for and undergo interviews with MHRA inspectors regarding internal processes and SOPs
• Conduct batch reviews and oversee QC testing protocols under GMP regulations
• Draft and review standard operating procedures to ensure ongoing regulatory compliance
• Support the operational requirements of the MHRA Manufacturer Specials licence

What you'll need

• Degree in pharmacy, chemistry, biology, microbiology, biochemistry or a related life science
• Minimum of five years relevant practical experience in a GMP regulated manufacturing environment
• Working knowledge of QC testing, batch review and product release under GMP
• Experience in cell and gene therapy or sterile and aseptic ATMP environments
• Professional registration or eligibility to be named as the person responsible for QC to the MHRA
• DBS clearance as required for regulated life science facilities

Please contact [email protected] if you are interested in this position.

Pay: £60,000.00-£90,000.00 per year

Work Location: In person