Executive - Quality Assurance

3 hours ago


Mahad, India Piramal Pharma Solutions Full time

Preparation and updation of Validation Master Plan (VMP)
- Preparation of Process validation, Computer system validation protocol and report.
- Preparation of product matrix and Cleaning Validation/verification protocol and Report.
- Preparation of qualification and requalification protocol and report for processing equipment/instrument, utilities, and facility.
- Preparation of area validation protocol and reports.
- Preparation and review of quality risk assessments.
- Review of calibration certificate (External/internal).
- Handling of Change control, deviation, incident.
- Statistical Process Monitoring.
- Audit compliance coordination, to compile CAPA and prepare response to Audit report in co-ordination with QA Head and technical team.
- Execution of requirements for food / Dietary supplements regulations for export market (US)-21 CFR Part 111
- Area and line clearance for Manufacturing, Packing & Dispensing activity in production area.
- In process 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.
- Online observation of process deviation and effective implementation of CAPA.
- Reporting of daily non conformance.
- 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.
- Execution of various initiatives as are suggested by corporate functions (SEEDS, Learning university, Quality mindset).
- Customer centricity.
- Document Archival.



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