About the role
Responsibilities
- To check the compliance with respect to SOP′s in
the manufacturing plants.
- Cross checking of temperature, humidity and
differential pressure monitoring records in the defined areas.
- To check the proper status of equipments, tanks
and instruments
- To prepare and review scale-up/optimization and
validation protocol and report.
- Handling of change control and coordinate for
deviation, out of specification, out of trend and other GMP documents.
- To review the qualification documents (URS, DQ,
IQ, OQ and PQ).
- To monitor the schedule of maintenance and
calibration of equipment and instruments is being followed.
- To prepare annual quality review of HVAC.
- Responsible for initiating/impact assessment of
the amendment.
- To
conduct assigned internal audits in different departments.
RequirementsAbove 4 years in QA API (Equipment Qualification & Validation)