Senior Quality Assurance Engineer - cGMP

Help bring an advanced nuclear medicine production facility into cGMP operation.

We are supporting an innovative nuclear technology company developing a first-of-a-kind medical isotope production facility
, designed to manufacture critical radioisotopes used in diagnostic imaging and cancer treatment.

They are looking for a Senior Quality Assurance Engineer to take a key role in the commissioning, qualification and validation of the facility, its equipment, utilities and cGMP manufacturing processes.

This is an opportunity to join a highly technical programme as it moves toward commercial production, with significant ownership over how its quality and validation systems are established.

You will be responsible for areas including:

• Establishing and executing the Master Validation Plan
• Equipment, utility and facility Commissioning & Qualification (C&Q)
• Developing Process Validation and Cleaning Validation programmes
• Supporting QC laboratory method validation
• Developing SOPs for qualification, requalification and revalidation
• Leading FMEA/PFMEA and risk assessment activities
• Software and process-control validation
• Stability testing plans and protocols
• Supplier audits and Approved Supplier List development
• Reviewing validation data and producing final qualification/validation reports
• Working closely with Engineering, Production, Chemistry, QC and external stakeholders

• 5+ years of Quality Assurance or Validation experience within a cGMP pharmaceutical/manufacturing environment
• Strong knowledge of 21 CFR and cGMP requirements
• Experience establishing and executing C&Q / validation programmes
• Understanding of regulated laboratory methods and instrumentation
• Bachelor's degree in Engineering, Radiochemistry, Life Sciences or a related discipline
• Radiopharmaceutical experience would be highly desirable
• Comfortable operating in a technically complex, highly regulated environment

This isn't maintaining an established QA programme. You'll have the opportunity to help build and qualify a first-of-a-kind facility
, working at the intersection of nuclear technology, radiopharmaceutical manufacturing and cancer medicine
.

If you have strong cGMP validation experience and want to work on something considerably more interesting than a conventional pharmaceutical manufacturing facility, I'd be keen to speak.