SENIOR ASSOCIATE

Department Details

Role Summary

1.Ensure adherence to cGMP requirements.

2. Ensure adherence to EHS compliance at QC Analytical Laboratory.

3. Ensure Good Documentation Practise (GDP) is in place and applied in recording of QC daily activities for easy traceability and facilitate audit requirement.

4. Ensure the proper housekeeping and cleanliness is maintained in the laboratory.

5. Ensure proper safe and regular disposal of laboratory waste such as solvent, reagents and etc. following EHS Department and local regulation.

6. Ensure the laboratory facilities and equipment are well maintained as per recommended requirement.

7. Performing routine analysis of Raw Materials, Packaging Materials, Consumable samples, In-Process, Finished product and Stability samples according to SOP / Test procedure.

8. Perform day of use calibration / verification on equipment's as per training and SOP.

9. Performing routine sampling of Raw Materials, Packaging Materials, Consumables as per given schedule.

10. Performing sampling and testing for tanker and recovery solvent samples.

11. To prepare reagents, test and volumetric solution according to procedure and specification.

12. To review the ATR's Raw Materials, Packaging Materials and Water.

13. SAP and Track wise activities as per the designated roles.

14. Knowledge on the analytical instruments / hands on experience on HPLC,GC, AAS, KF, Potentiometer, Polarimeter, UV, IR.

15. Quality management system handling experience (Change controls, CAPA, Deviation, OOS & OOT investigations)

Key Responsibilities

1. Ensure adherence to cGMP requirements.

2. Ensure adherence to EHS compliance at QC Analytical Laboratory.

3. Ensure Good Documentation Practise (GDP) is in place and applied in recording of QC daily activities for easy traceability and facilitate audit requirement.

4. Ensure the proper housekeeping and cleanliness is maintained in the laboratory.

5. Ensure proper safe and regular disposal of laboratory waste such as solvent, reagents and etc. following EHS Department and local regulation.

6. Ensure the laboratory facilities and equipment are well maintained as per recommended requirement.

7. Performing routine analysis of Raw Materials, Packaging Materials, Consumable samples, In-Process, Finished product and Stability samples according to SOP / Test procedure.

8. Perform day of use calibration / verification on equipment's as per training and SOP.

9. Performing routine sampling of Raw Materials, Packaging Materials, Consumables as per given schedule.

10. Performing sampling and testing for tanker and recovery solvent samples.

11. To prepare reagents, test and volumetric solution according to procedure and specification.

12. To review the ATR's Raw Materials, Packaging Materials and Water.

13. SAP and Track wise activities as per the designated roles.

14. Knowledge on the analytical instruments / hands on experience on HPLC,GC, AAS, KF, Potentiometer, Polarimeter, UV, IR.

15. Quality management system handling experience (Change controls, CAPA, Deviation, OOS & OOT investigations)

Educational Qualifications

Required Education Qualification : Msc

Required Experience : 6 - 8 years