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.
Requirements
Above 4 years in QA API (Equipment Qualification
& Validation)