Senior Executive - Quality Assurance

Job Description

1. To perform In-process quality control checks at regular intervals during manufacturing & packaging operations and verify Raw material/Packaging material issuance activities.
2. 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.
3. To perform swab sampling activities of equipment’s and periodic monitoring.
4. To perform line clearance of manufacturing and packaging operations.
5. Preparation of calibration planner and calibration of IPQC Apparatus.
6. To prepare Standard Operating Procedures (SOPs) in EDMS Software.
7. Review of Batch manufacturing records and Batch packaging records prior to release finished product.
8. Preparation of data for Annual Product Quality Review.
9. Review of Qualification, Validation and other QMS documents.
10. Handling of Batch production records and submission to Doc-cell.
11. Review of Master Batch Manufacturing records and Batch packaging records in SAP software.
12. To perform other IPQA activities i.e. Periodic logbook review, Line clearance challenge Test, Periodic visual inspector qualification and periodic monitoring of Swab Samples.
13. Release of finished products in oral cephalosporin formulation facility.
14. Handling of change control, deviation, CAPA etc. in QAMS.
15. Handling of Quality Risk Management.
16. Handling of activates related to nitrosamine and elemental impurities.
17. To carry out self-audit.
18. To ensure compliance of GMP on shop floor and documentation.

Work Experience

12 to 15 years

Education

Competencies