Location: Gangtok, Ranipol, Guwahati, Halol, Baska, Vadodara.

Responsible for the activities wrt to testing, planning, compliance, qualifications as per Laboratory Practices requirements, Distribution of work to team, ensuring availability of resources and handling of OOS/OOT (Deviations and investigations).

The incumbent will assure individual compliance with the all concerned regulatory requirements, GxP’s and applicable department programs, including training, documentation, standard operating procedures, and Sun Pharma global policies, standards and procedures.

Key responsibilities:

1. Ensure timely sampling and analysis of materials as per approved procedures.

2. Perform work allocation to analysts depending upon the product release schedule

3. Perform review of analytical raw data and certificate of analysis.

4. Adherence to data reliability practices.

5. Ensure availability of all chemicals, consumables, standards, columns etc, for timely testing and release of samples.

6. Review audit trials reports generated during analysis

7. To initiate and ensure timely completion of investigate OOS, OOT and lab events.

8. To review sample set and instrument methods

9. To ensure all documentation as per GLP requirements are in place

10. To ensure review of respective SOPs and their timely revision as and when needed.

11. Follow the EHS policy, laboratory standard operating procedures and maintain the compliance to GMP requirements

MINIMUM EDUCATION/EXPERIENCE REQUIREMENTS

Science and Pharmacy Graduates or Equivalent

5 years with QC work experience preferred.

REQUIRED SUCCESS ATTRIBUTE

· Knowledge of GxP’s, cGMP and other regulatory requirements.

· Attention to detail

· Initiative

· Learning Agility

· Compliance

Secondary Success Attributes

· Collaboration

· Effective Communication

· Passion

Roles

Additional responsibilities can be assigned as required. See Less