1. Responsible for routine monitoring of Manufacturing Areas.

2 Responsible for the routine GMP Inspection & review of Quality Records of other departments.

3 To monitor and ensure compliance level of organization is as per current GMP requirement

4 Good Documentation recording and updation.

5 Responsible for review of URS, DQ and vendor / suppliers documents related to qualification.

6 Responsible for preparation of Validation / Qualification protocol and report.

7 Responsible for execution and review of qualification / Re-Qualification and Validation activity of Equipment / System / Facility and Plant Utilities.

8 Responsible for adequacy of execution of validations being carried out at prescribed procedures.

9 Responsible for assurance of calibrations before performing qualifications.

10 Responsible to co-ordinate with cross functional department personnel for respective Qualification / Validation / Re-qualification activity for timely completion of activities.

11 Responsible for preparation of Standard Operating Procedures of Quality Assurance Department.

12 Responsible to check production shop floor compliance.

13 Responsible for preparation and review of VMP.

14 Responsible for preparation, review, execution data and compilation updation of validation related documents.

15 Responsible for handling of failures during qualification by using QMS tools.

16 Responsible for Preparation, review and execution of risk assessment activity related to Equipment / Process / Facility / System.

17 Viable monitoring in clean area of manufacturing and warehouse as per the defined schedule.

18 Responsible for personnel monitoring.

19 Responsible to participate in qualification, requalification, area qualification activities.

20 Calibration certification review and approval

Qualifications