Quality Assurance Specialist

Core Purpose of the Role :

Experience - 8 to 10 years

Line Clearance process overview, Product change over.

Timely area readiness (Cleaning, EMS, OOS status) and ensures availability of documents and material status.

Monitoring of process through process step verification.

Reviewal of Batch Manufacturing Record to check compliance from stepwise process execution till written instructions.

Equipment / utility Qualifications, Calibrations, PM verification.

Utility / Computer system validation

Process validation and cleaning validation.

Target Monitoring for batch related process activities.

cGMP compliance and verification overview of BMP facility & Utilities.

SOP preparation and review.

Training

GEMBA principles

Quality management system, investigatio