Executive - Quality Assurance
Role Overview
The Executive - Quality Assurance ensures compliance with quality systems, cGMP requirements, and regulatory standards in a manufacturing environment.
The role supports product quality, documentation management, regulatory readiness, continuous improvement, and EHS adherence.
Key Skills for This Role
Full Job Posting
Role overview
The Executive - Quality Assurance ensures compliance with quality systems, cGMP requirements, and regulatory standards in a manufacturing environment.
The role supports product quality, documentation management, regulatory readiness, continuous improvement, and EHS adherence.
Responsibilities
- Review executed BMRs, ECRs, analytical raw data, and documents in Ensur Software.
- Prepare process validation protocols and reports, monitor process validation, and handle cleaning validation.
- Carry out dispatch and line-clearance activities; prepare and review SOPs and Annual Product Reviews.
- Review analytical data and audit trails, support batch release, and initiate deviations and change controls as needed.
- Issue, archive, and retrieve R&D and ADL documents; manage related quality activities and review and approve documents.
Qualifications and experience
- Qualification: M.Sc. (Chemistry), B.Pharm, or M.Pharm.
- Experience: 1–3 years.
Skills and competencies
- Good knowledge of cGMP, GDP, and pharmaceutical quality systems.
- Experience with BMR, ECR, MMF, and analytical data review.
- Understanding of Quality Control analytical documentation and data integrity requirements.
- Familiarity with APR/PQR preparation and documentation.
Stakeholders and reporting
Internal stakeholders include Production, Quality Assurance, Quality Control, and Engineering teams.
External stakeholders include auditors, suppliers, and customers.
Reports to the Deputy Manager - QA.
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