Assistant Manager Quality Assurance

Position           : Assistant manager
Section            : Analytical Quality Assurance                   

Qualification    :    M.Sc. /B. Pharm.

Desirable Experience: 12-14 years

Followings will be the responsibilities of the position holder:

1. Quality Management System (QMS): Must be well-versed in handling QMS systems, including documentation, audits, CAPA, and compliance activities.

2. OOS/OOT & Investigations:

Proven experience in managing Out of Specification (OOS) and Out of Trend (OOT) incidents.

Should have handled both Phase-I and Phase-II investigations independently, with thorough documentation and root cause analysis.

3. Preferably has worked with Abbott for a minimum of 3 years, demonstrating familiarity with their quality standards and operational procedures.

4. To ensure effective implementation of system and procedure as per cGMP, cGLP and other Regulatory requirements, and monitor its compliance.

5. To participate in investigation exceptions, market complaints and review the investigation report.

6. Practical understanding of HPLC (Empower software) , GC and laboratory instrument handling.

7. To act as a laboratory compliance administrator for creation of new users and projects and to review the audit trials.

8. Handling of QMS activities (Change Control, Deviations, Exceptions, CAPA, Market complaints, Effectiveness Checks) To ensure the effective implementation of QMS through TrackWise system.

9. Ensure Compliance of QMS related SOPs /records.

10. To strategize and plan continual improvement in all laboratory activities as per GMP and GLP requirements.

11. Review, approval of qualification and Validation documents (URS, DQ, IQ, OQ, PQ etc.)

In specific locations, the pay range may vary from the range posted.