Section Head - QMS & Compliance

Job Purpose

Plan, coordinate for audits and track the compliance of contract manufacturing units / PTL, monitor the implementation of QMS, review all master documents and APQR data and perform timely release of batches manufactured as per process in order to ensure capability of contract manufacturing units to manufacture and deliver quality products and meet regulatory compliance.

Accountabilities

I. Plan and conducts the audits of existing / new proposed CMOs/PTLs, review audit non-compliance and recommend CAPAs to ensure manufacturing unit can produce quality products
II. Plan and execute the risk management programme for contract manufacturing units to identify, prioritize and mitigate quality risks for patient safety and product quality
III. Review and approve the deviations, change request and CAPA in order to ensure quality product release in market and no recurrence of the deviation with compliance cGMP
IV. Review and approve the market complaint to ensure adequate investigation is done to find out root cause and CAPA to avoid reoccurrence of similar nature of market complaint and no impact on patient safety and regulatory compliance.
V. Review the batch failure and recall of batches due to process error, stability issue, complaints etc. by ascertaining all the aspects of investigation thereby ensuring that no product deficient is released in market and no defective product is available in the market leading to regulatory action and patient health impact
VI. Review batch release documents of contract manufacturing units to ensure the quality of product release in market within time to meet the regulatory requirements
VII. Review and assess master batch documents to ensure all the required instructions are maintained to manufacture quality product while meeting customer and regulatory requirements