Quality Control Analyst (Wet Lab)

Main Responsibilities:

1. 24 x 7 audit readiness.

2. Participation in internal, external, regulatory audits.

3. Ensure 100% participation in trainings against CAPAs.

4. Responsible for initiation and investigation on LIR, OOS, OOT & boarder line results and reporting them to the in-charge.

5. Supporting to share required documents from QC to RA/ other requirement.

6. Determining team priorities in accordance with the plants needs, while coordinating with the team leader /Manger.

7. Follow up the housekeeping, cGMP, GLP and Safety Guideline in laboratory.

8. Sampling and analysis of RM / FG / intermediates / cleaning samples based on requirement and result entry in analytical sheet, QA form, LIMS and online documentation as per data integrity norms.

9. Perform analytical test according to the monograph and SOP.

10. Responsible for calibration and verification of instruments.

11. Responsible to work in shift as per requirement.

13. Help in preparation of documents related to department (like STPs, SOPs and etc.)

14. Ensure the sampling of finished products, Raw material, Intermediate and sending sample to outside laboratory for analysis.

15. Must be ensured sampled, approved and rejected labels timely as required.

16. Responsible to maintain the stock record of chemicals and reconciliation of standards.

17. Responsible to maintain safety CAPA.

18. Responsible to maintain 5-S in QC.

19. Online documentation (based on requirement) must be ensured as per data integrity norms and awareness to team against data integrity.

20. Responsible to support analysis reduction/QC efficiency enhancement programs.

21. Any other job assigned by the Manger - QC Manger or group leader - QC

Preferred Skills:

Preferred experience with Wet lab instruments/techniques including but not limited to Karl Fischer Titrator, Auto-titrator, analytical balance, FTIR, Polarimeter, UV, X-ray Diffraction, etc.

Qualifications

The ideal candidate will have:

• Education:

• Experience:

• Preferred Industries: