QA Executive – Pharma (2-8 Years)

Key Responsibilities

Ensure implementation and compliance with cGMP, GLP, GDP, and regulatory guidelines (WHO, USFDA, EU-GMP, Schedule M).

Review and approve Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), SOPs, specifications, and protocols.

Handle deviations, change controls, OOS/OOT investigations, CAPA, and risk assessments.

Monitor in-process quality checks and finished product documentation.

Participate in internal, external, and regulatory audits and ensure timely closure of audit observations.

Perform and review validation activities including process validation, cleaning validation, and equipment qualification.

Control and maintain QA documentation, logs, and quality records.

Coordinate with Production, QC, Engineering, and Warehouse teams for quality-related activities.

Support product release and market complaint handling.

Ensure compliance with data integrity and documentation practices.

Required Qualifications:

B.Pharm / M.Pharm / B.Sc / M.Sc (Chemistry or related discipline)

1-5 years of experience in Quality Assurance within a pharmaceutical manufacturing environment

Strong knowledge of GMP documentation and regulatory compliance

Preferred Skills & Competencies:

Hands-on experience with regulatory audits (WHO / USFDA / MHRA)

Knowledge of pharmaceutical quality systems (QMS)

Good understanding of validation and qualification procedures

Strong analytical, documentation, and problem-solving skills

Proficiency in MS Office and quality management systems

Good communication and coordination abilities

Industry:

Pharmaceuticals / API / Formulations