Quality Assurance Engineer

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)