Quality Assurance

Job Description:

The Quality Assurance professional is responsible for ensuring that pharmaceutical products are manufactured, tested, and released in compliance with GMP and regulatory requirements. The role focuses on documentation, compliance, audits, and continuous quality improvement.

Roles and Responsibilities

GMP & Compliance

• Ensure compliance with GMP, GDP, GLP, and regulatory guidelines

• Review and approve SOPs, BMRs, BPRs, and other GMP documents

• Monitor manufacturing and packaging operations for compliance

Documentation & Record Control

• Prepare, review, and control SOPs, protocols, and reports

• Review Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR)

• Maintain document control and archival systems

Quality Systems

• Support validation activities (process, cleaning, equipment, computer systems)

• Participate in annual product quality review (APQR/PQR)

Audits & Inspections

• Participate in internal audits and external regulatory inspections

• Support inspections by USFDA, MHRA, WHO, EU authorities

• Coordinate responses to audit observations

Training & Continuous Improvement

• Conduct GMP training for employees

• Ensure implementation of quality improvement initiatives

• Support quality culture and compliance awareness

Product Release

• Review analytical and manufacturing data for batch release

• Ensure only compliant products are released to the market

Skills & Competencies

• Excellent documentation and communication skills

• Knowledge of ICH guidelines and regulatory expectations

• Attention to detail and problem-solving skills