Senior Executive – Quality Assurance

• To perform In-process quality control checks at regular intervals during manufacturing & packaging operations and verify Raw material/Packaging material issuance activities.
• To perform sampling of finished products samples/in-process samples, stability samples, control samples, micro samples and blend uniformity samples and, swab sampling of equipment’s.
• To perform swab sampling activities of equipment’s and periodic monitoring.
• To perform line clearance of manufacturing and packaging operations.
• Preparation of calibration planner and calibration of IPQC Apparatus.
• To prepare Standard Operating Procedures (SOPs) in EDMS Software.
• Review of Batch manufacturing records and Batch packaging records prior to release finished product.
  Preparation of data for Annual Product Quality Review.
• Review of Qualification, Validation and other QMS documents.
• Handling of Batch production records and submission to Doc-cell.
• Review of Master Batch Manufacturing records and Batch packaging records in SAP software.
• To perform other IPQA activities i.e. Periodic logbook review, Line clearance challenge Test, Periodic visual
• inspector qualification and periodic monitoring of Swab Samples.
• Release of finished products in oral cephalosporin formulation facility.
• Handling of change control, deviation, CAPA etc. in QAMS.
• Handling of Quality Risk Management.
• Handling of activates related to nitrosamine and elemental impurities.
  
  

Work Experience: 12 to 15 years

Pharma Quality Assurance in Formulation / Solid Orals

GMP documentation and review - Batch records, APQRs, QMS documenta

Graduation in Pharmacy / Masters in Pharmacy