Quality Assurance Analyst

Key Skills

Communication Skills Organic Chemistry Method Development Change Control OOS & OOT Investigations Of Incidents Quarterly & Annual Calibrations Schedules Stability Study Initiation As Part Of CCF Review Of IM FP AWS Records Master STP Relevant Work Sheet AR Review Quality Analyst QMS

Job Description

1. Master STP and relevant work sheet and AR review/ revision.

2. Analytical Method validation protocol, monitoring and report (9 No's - 2020)

3. Investigations of incidents (139 No's - 2020)

4. QC SOP revision (Review, Print, signature followup)

5. Review of daly, monthly, quarterly and annual calibrations and schedules.

6. Organized data backup as per the schedule

7. Stablity study initiation as part of CCF/ Add on batch. accordingly protocols to be review and approval

8. Review of IM & FP AWS records

QMS:

12. Change control handling (66 No's)

13. Deviation Handling

14. OOS handling

15. Weekly meeting preparation

16. MRM preparation

17. Audit support.

18. CAPA followup

19. CAPA effectiveness

20. Internal audits followup and closure

Experience : 5 - 9 Years

No. of Openings : 02

Role : Quality Assurance Analyst

Industry Type : Manufacturing / Production / Quality

Gender : Male

Job Country : India

About Kreative Organics Private Limited

Kreative Organics Private Limited is a manufacturer of Active Pharmaceutical Ingredients (APIs) for the world market. Kreative started operations in 1990.
Kreative was established by Dr. S. Krishnamohan. Dr. Krishnamohan was formerly with TIFR, BARC, Caltech and NASA. He is a scientist of international repute and runs Kreative with professionalism and a focus on innovation.
Read More...

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