Required Skills

CAPA QA SOP Method Validation Bioanalytical QA Archives

Work Authorization

  • Citizen

Preferred Employment

  • Full Time

Employment Type

  • Direct Hire

education qualification

  • UG :- - Not Required

  • PG :- - Not Required

Other Information

  • No of position :- ( 1 )

  • Post :- 23rd Nov 2022


Roles and Responsibilities


1. Quality audits in Bioanalytical Process i.e. in-process and retrospective audit of raw data and reports generated for projects and Method Validation in compliance with Regulatory guidelines, In-house SOPs and protocol.

2. Archives documents according to prevailing standards.

3. Accountable for preparation of training program/ training log or training needs to all internal department personnel.

4. Provides training to concerned persons based on the training plan.

5. Effectively manages training documentation of departmental personal and new joiners.

6. Plays an active role in the preparation and conduct of internal and vendor qualification audits.

7. Support to external and health authority inspections.

8. Accountable for tracking change control and deviations to all SOPs or impacting and escalating issues.

9. Accountable for review of CAPA, maintain CAPA records and ensure the CAPA implementation.

10. Collates and reviews compliance data from cross functional departments, if applicable.

11. Co-ordinates in activation of crisis management plan.

12. Review and monitoring of calibration, qualification documents of instruments/equipment's.

13. Handling of Quality Management system.

14. Accountable for preparation and review of QA department Standard Operating Procedures (SOPs).

15. Accountable for review or/and approval of all departments Standard Operating Procedures (SOPs).

16. Responsible for documentation and monitoring of incident, deviations investigation/event reports.

17. When appointed as lead auditor, perform the duties assigned in an efficient and effective manner.

18. Execute additional QA responsibilities as directed by the QA manager.

19. Verification of the bioanalytical lab compliance.

20. Adequate knowledge in M.S Office, Outlook

21. Good communication skills in English.


Desired Candidate Profile


Perks and Benefits


Company Information