Team Member - QMS & Compliance

Job Purpose

Coordinate for audits and track the compliance of non-conformances, ensure implementation of QMS system, review all master documents and APQR data and perform timely release of batches manufactured at CMO/PTL sites to deliver quality products and meet regulatory compliance

Accountabilities

I. Review batch release documents of CMO/PTL sites to ensure the quality product is released in market to meet the regulatory requirements and patient safety
II. Evaluate logged deviation and change control for investigation and CAPA implementation in order to ensure no recurrence of the deviation
III. Initiation and track the batch failure investigation, product recall and Implementation of CAPA to avoid reoccurrence of batch failure and recall
IV. Identify exact root cause for market complaints and ensure implementation of CAPA in order to avoid reoccurrence of complaint in future and no impact on patient safety and compliance of regulatory requirements
V. Plan, execute audits of CMO/PTL sites to ensure manufacturing unit can produce quality products and PTL meets the testing requirements
VI. Plan and execute risk management programme for CMO/PTL sites to identify, prioritize and mitigate quality risks
VII. Review master batch documents to ensure it contains all the required instructions to manufacture quality product meeting customer and regulatory requirement

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