The Contractor is a member of a team within Development Quality and is involved in supporting the GMP Quality
Assurance activities at the Hoddesdon site.
Key Result Areas and Primary Activities
• Completes review of data, information, procedures, facilities, equipment and systems (inc computer systems) to
ensure compliance to SOPs, GMPs and applicable regulations.
• Review and approve production and analytical documentation accompanying the release of drug substance, drug
product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory
requirements, including supporting QP certification.
• Actively communicate and collaborate with functional areas to develop a strong working relationship and
understanding of roles and responsibilities. Utilise this network to help resolve comments and issues that arise
during audit and review.
• Support product recalls and stock recoveries as appropriate.
• Identify compliance gaps and make recommendations for continuous improvement
• Creates and maintains assigned SOPs.
• Perform and review complaints and deviation investigations, change controls and CAPA’s.
• May assist in the induction process for new starters.
• Generally follows standard procedures and consults with manager/supervisor on exceptions.
• Compiles data for reports and presentations - May interpret data and draw conclusions.
• Carries out all assignments to the standards of compliance, efficiency, innovation, accuracy and safety in
accordance with Company and regulatory requirements.
• Keep abreast of cGMP requirements as described in applicable worldwide regulations.
• Additional activities may be assigned by the manager/supervisor
• The contractor is required to possess a degree in an Engineering or Science discipline.
• Alternatively they must possess significant industrial experience
Certified Global Meeting Planner
Corrective And Preventive Action (Capa)
Good Manufacturing Practices