Hobson Prior are currently seeking a QA Specialist to join a top biotechnology organisation on a permanent basis in Stevenage. Our client concentrates on developing pioneering gene therapies to enable people living with chronic diseases live a better life. As the QA Specialist you will be primarily responsible for providing GMP QA support to the organisations manufacturing operations.

Job Responsibilities:

• Review executed batch manufacturing records for compliance with GMP.
• QA approval of manufacturing PPM and calibration activities.
• Perform room release checks prior to manufacturing activities.
• Compile Product Specification Files.
• Review facility EM trends for approval by QA Manager (GMP) - viable/ non-viable, temperature/ humidity and differential pressures.
• Assist with internal audits of GMP manufacturing activities as required.
• Participate in external audits as required.
• Primary point of QA contacts all CGT-related GMP deviations and change control assessments.
• Witnessing receipt of biological raw materials.
• Approve/ reject raw materials for use in manufacturing at CGT.
• Assist with validation / qualification activities as directed by QA director.

Requirements:

• Previous GMP experience in sterile/aseptic manufacturing.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.