The Senior Executive-QA role involves overseeing quality assurance in manufacturing, packing, and dispensing activities, ensuring compliance with regulations and maintaining data integrity. Responsibilities include in-process checks, equipment cleanliness verification, and online batch manufacturing records review.
Requirements
- Area and line clearance for Manufacturing, Packing & Dispensing activity in production area.
- Inprocess checks in Manufacturing and Packing activity.
- Inspection of dispensing activity intermediately.
- Daily verification of weighing balance calibration activity.
- Daily verification of environmental monitoring of raw material staging area and Manufacturing and Packing area.
- Verification of each equipment cleanliness and area cleanliness during line clearance
- Verification and review of online Batch Manufacturing Records.
- Sampling of bulk stage and finished goods analysis and control sample.
- Verification of production documents.
- Daily non conformance observation reported and maintained.
- In process quality checks in Tablet, Liquid, HNH, ANH manufacturing dept.
- Line Clearance for Manufacturing, Packing & Dispensing activity.
- Sampling of Bulk and Finished goods
- Review of production records and Finished Goods verification
- On job training to the new people working in the production area.
- Statistical Process Monitoring.
- Online observation of process deviation and effective implementation of CAPA.
- Reporting of daily non conformance.
- Execution of requirements for food/Dietary supplements regulations for export market (US)-21 CFR Part 111
- Ensuring avoidance of breach of data integrity in area.
- Implementation of effective sanitation program in area.
- Imparting required training to shop floor personnel.
- Adherence to the requirements of EHS norms.
- Audit compliance, Qualification and validation activities