EXECUTIVE
- India
- Permanent
- Full-time
2. Inspection, testing of material (In process samples, finished product samples and stability samples).
3. To collect samples and carry out all testes and to issue test reports as per documented procedures.
4. Corrective action and preventive action as and where applicable.
5. Traceability and arrangement of reserve samples and stability samples.
6. Monitoring and maintaining of daily temperature records.
7. Maintenance and calibration of Measuring and Testing Instruments/equipment belonging to the Quality Control (Analytical) laboratory.
8. Generation and maintenance of Quality records.
9. Preparation and adherence to product Specification.
10. Preparation and review of Analytical reports.
11. Recording and reporting of laboratory incidents, OOS and Deviations.
12. Arrangement of documents and analytical reports.
13. Ensuring effective implementation of EHS management system in the organization.
14. To communicate relevant EHS issues to concerned personnel.
15. Maintaining co-ordination with cross functional teams. 16. Temperature mapping of all Stability chambers and Humidity Chambers. 17. Analysis of Finished product, Stability, Medical device, Validation and Stress studies. 18. Maintenance of Standard and HPLC Columns. 19. Preparation of URS, DQ, IQ, OQ, PQ documents for equipment qualification. 20. Performing Excel sheet validation. 21. Sampling of Incoming Device components and analysis of the samples. 22. Initiation of Quality Management system documents Deviation, CAPA, Incidents, specification and Change control as applicableKey Responsibilities1. Adherence to cGMP (Current Good Manufacturing Practice) and cGLP (Current Good Laboratory Practice).
2. Inspection, testing of material (In process samples, finished product samples and stability samples).
3. To collect samples and carry out all testes and to issue test reports as per documented procedures.
4. Corrective action and preventive action as and where applicable.
5. Traceability and arrangement of reserve samples and stability samples.
6. Monitoring and maintaining of daily temperature records.
7. Maintenance and calibration of Measuring and Testing Instruments/equipment belonging to the Quality Control (Analytical) laboratory.
8. Generation and maintenance of Quality records.
9. Preparation and adherence to product Specification.
10. Preparation and review of Analytical reports.
11. Recording and reporting of laboratory incidents, OOS and Deviations.
12. Arrangement of documents and analytical reports.
13. Ensuring effective implementation of EHS management system in the organization.
14. To communicate relevant EHS issues to concerned personnel.
15. Maintaining co-ordination with cross functional teams. 16. Temperature mapping of all Stability chambers and Humidity Chambers. 17. Analysis of Finished product, Stability, Medical device, Validation and Stress studies. 18. Maintenance of Standard and HPLC Columns. 19. Preparation of URS, DQ, IQ, OQ, PQ documents for equipment qualification. 20. Performing Excel sheet validation. 21. Sampling of Incoming Device components and analysis of the samples. 22. Initiation of Quality Management system documents Deviation, CAPA, Incidents, specification and Change control as applicableEducational QualificationsRequired Education Qualification: M.Sc
Required Experience: 1 - 3 years