As a Senior Associate Contractor Operation Quality Assurance:
- you initiate, review and approve regulatory changes through PDM for changes initiated by or impacting COQA managed Contract manufacturers.
- you provide support for the closure of the deficiency letters and CMC Commitments, Regulatory requests for Renewals, New Product registrations and Post approval variations.
- you serve as the main point of contact for the Global Chemistry, Manufacturing and Controls (GCMC) department or Local Regulatory Affairs for the various regulatory activities involving COQA managed Contract manufacturers.
- you participate in Virtual Site Operating Teams (VSOT) (or similar) meetings for ES/COQA managed Contract manufacturers and if needed, participate in Site Quality visits at the Contract manufacturers.
- you manage routine Customer Quality complaints for commercial Drug Products in PCOM and work in collaboration with the COQA Contractor Quality Lead for ensuring that the investigation reports are appropriate and acceptable. Ensure timely closure of complaints and alerting the appropriate colleagues as per our procedure and Standard Work guidance.
- you support and Perform Lot Disposition for Biotech products in collaboration with other functions.