Executive - Quality Assurance

This opening is for Cotecna Life Sciences India Pvt Ltd.(Formerly known as Geochem Laboratories Pvt Ltd)

Qualification : M.Sc(Chemistry)

No of requirements : 1

Location : Digha (Navi Mumbai)

Year of Experience : 6 to 8 years' of experience (QA & QC)

Job Descriptions

1. Review of audit trial Monthly basis for 21 CFR software.

2. To Approve the Protocol and report for method validation.

3. To Approve part in Master module in LIMS.

4. Review for initial approval in Deviation, CCR, CAPA, OOS and Incident

5. To Approve the activity with respect to Deviation and OOS.

6. To Approve Qualification document (IQ, OQ and PQ).

7. To Approve Review General protocol and report.

8. Monitor Effectiveness check with respect to CAPA.

9. Prepare Audit Plan and Compliance of the Audit observations.

10. Monitor Instrument calibration and PM schedule.

11. Prepare QMS trend.

12. Review sample reconciliation record.

13. Review quality agreement.

14. Insure lab readiness for audit.

15. Spot check activity.

16. Verification Document with respect IT related Work

Like: Backup restoration verification, Date time synchronization record and Deviation related Backup failure

17. Released COA and ROA .

18. Prepare or Review method waiver in case of Method transfer.

19. Fill pre–Audit Checklist which will receive from Client before Client audit.

20. Review spread sheet validation Plan and report.

Work Location

Cotecna Life Sciences India Private Limited (Geo-Chem Laboratories)

Ganpati Pada, Plot 39, Indal Colony, TTC Industrial Area, Kalwa, Navi Mumbai, Digha, Thane, Maharashtra

In case interested please share updated resume on [email protected] or for any more information please call on 9870476784

Job Type: Full-time

Pay: ₹500,000.00 - ₹650,000.00 per year

Benefits:

• Health insurance
• Leave encashment
• Life insurance
• Provident Fund

Schedule:

• Day shift

Work Location: In person