Job Summary

The Quality Assurance Officer is responsible for ensuring that products, services, and processes meet established quality standards and regulatory requirements. The role involves monitoring quality control systems, conducting inspections and audits, identifying areas for improvement, and supporting continuous quality enhancement initiatives.

Key Responsibilities

• Prepare and review GMP documents like MFPI, BPPR, SOP, Specification, Protocols etc.

• Review Batch Manufacturing Record and Analytical Report/COA

• Handle Incident/Deviations, OOS and complaints

• Perform QRM, APQR, Trend Analysis and RCA

• Participate in Machine and Instrument Calibration/Qualification, Process Validation, Hold Time Study, Cleaning Validation

• Perform IPQA , Sampling-Intermediate and Bulk, Line Clearance, Dispensing

Required Qualifications

• Bachelor's degree in Pharma, Quality Management, Engineering, Science, Business Administration, or a related field.

• Facilities as per company rules