Quality Assurance Officer

Role & responsibilities

(1) To perform the daily IPQA related activity and line clearance related activity..

(2) To monitor the plant critical areas like clean room (Manufacturing / Filling), Packing, labelling, OBD verification, water system, utility supply area etc. for the GMP compliance.

(3) To ensure the End to End Control in Manufacturing, packing and material storage activity

(4) To prepare and review GMP documents such as SOPs, protocol and other relevant documents.

(5) To review the executed batch manufacturing / packing records and review of COA & analytical data.

(6) Handling of Control sample management and review of stability sample management procedure and its compliance.

(7) To involved in process validation and cleaning validation activity.

(8) To review the Change control, CAPA, Deviation, Market compliant details and involve in investigation.

(9) Handling and review of non-conformance and its compliance procedure in consultation with respective department head.

(10) Conduct training to IPQA and production personnel for the IPQA activities

(11) To ensure the all QA and plant procedure compliance.

(12) To review the Documents like Master BMR / BPR / MFC / QC Specification (RM, PM, FP) / STP / Other external party document / stability study report / APQR etc.

(13) To participate in the internal / external audit and give compliance for the audit observation.

Preferred candidate profile

B. Pharma fresher