Contractor for quality assurance for PETIC department

Tender description

Following a regulatory inspection in November, PETIC is looking to source a temporary contractor to support quality assurance processes in PETIC for a period of 6 months in the first instance. Lot 1: PETIC requires QA support for managing workflows Documentation, quality trackers, Q-Pulse, completion and closure of paper and electronic records, as well as support for Supplier Management and executing self-inspections. In addition to these routine tasks, the contractor would need to assist with Quality Assessment of Deviations and Quality Events, assessment and approval of CAPA. Potential contractors need to have experience of QA activities within a GMP Manufacturing environment, given PETIC’s very specific and niche product portfolio, we require someone with an understanding of aseptic/sterile manufacture, and it would be desirable for them to have experience of radiopharmaceuticals, and an appreciation of remediation activities.