• Receipt, inspection, and release of client specific products to market. • Perform timely review and assessment of documents received from clients/foreign sites, including but not limited to, manufacturing and packaging records, Certificates of Analysis, Certificates of Manufacture, and other product release documents. • Coordinate with clients and/or foreign sites for the receipt, review, and updates to master documents to ensure compliance to GMPs and in relation to product release activities. • Maintain and review in-house and client-based quality documents such as APQR, stability reports, equipment and facility qualification/validation protocols and reports, product label, temperature study etc. • Investigate and document any discrepancies recorded during product handling and ensure product disposition decisions are made in conjunction with client and GMP regulations.

• Perform product sampling, and inspection of incoming products.• Assist in the generation and execution of equipment/facility protocols.• Execute facility temperature monitoring and excursion investigations.• Assist in SOP revision/updates.• Coordinate/execute Product Rework activities according to approved instructions.• Assist in quality investigations (Deviations, Complaints).• Assist in the Validation of equipment / Facility (IQOQ and PQ) and execute validation of cold chain pack outs.• Assist in the inspection and assessment of wholesale returns and update the log.• Perform investigations independently to assess aberrant events impacting product quality that could prevent product release.