Providing Quality oversight for Tech Transfer Projects to ensure compliance with regulatory and cGMP requirements during the design, qualification and operational readiness phases for a number of site critical projects.
• To provide consultative support on quality related issues to project teams.
• Participate in cross-functional teams as required.
• Ensuring all production steps have been performed and verified, that all limits and specifications have been met.
• QA support for qualification activities – review and approve equipment/utility qualification documentation from design to post-execution.
• Review/approval of technical documentation.
• Review/approval of production instructional documentation (SOPs and batch records) to ensure they are up to date, compliant, and support efficient production,
• Carryout cGMP compliance area walk-throughs of Manufacturing Operations as required.
• Participate in the internal audit programme as required.
• Maintain tracking system for project document review status.
• Review event/investigation reporting including support of Manufacturing Operation teams with investigations and resolution of discrepancies.
• Co-ordinate and review change controls as required.
• Perform completion of batch disposition packs within required timelines /Work with site QPs to ensure timely issue resolution to final disposition.
• Review of regulatory documentation
• Assist in the creation and maintenance of up to date QA policies, SOP’s and reports.
• Assist in the development of training curricula and records for the QA Operations Group.
• Perform and assist with additional duties as may be directed by the QA Ops Lead.
• B.Sc. degree in biology, chemistry, or another related technical degree.
• Min 4 years working experience in a pharmaceutical manufacturing environment, preferably in a quality assurance or quality control role.
• Previous QC/QA and/or pharmaceutical experience in a GMP or GLP facility.
• Excellent communication and interpersonal skills.
• An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.