Sr. Executive – Quality Assurance (QMS)
Department: Quality Assurance (QMS)
Location: Saharanpur
Experience: 4–8Years
Qualification: B.Pharm / M.Pharm / M.Sc. (Chemistry, Microbiology, Biotechnology) or equivalent
Salary: 25,000–30,000 per month (Negotiable)
Roles, Responsibilities & Authorities
- Ensure compliance with ALCOA+ principles and maintain QMS documentation.
- Assist in the preparation of product registration, variation, and renewal dossiers.
- Support calibration, qualification, and preventive maintenance activities for laboratory instruments.
- Assist in the implementation of verification, validation, and change control activities.
- Participate in internal quality audits and ensure timely closure of audit observations.
- Maintain recall documentation and assist in mock recall activities.
- Ensure compliance with GMP, GLP, WHO-GMP, Schedule M, and company SOPs.
- Operate and maintain analytical instruments such as HPLC, UV-Visible Spectrophotometer, Karl Fischer Titrator, and IR Spectrophotometer.
- Support regulatory inspections by preparing documents and coordinating with departments.
- Review and maintain specifications for raw materials, APIs, and packaging materials.
- Coordinate internal and external product testing activities.
- Assist in developing and maintaining QA/QC procedures and documentation.
- Record deviations, participate in Root Cause Analysis (RCA), implement CAPA, and monitor timely closure.
- Assist in preparing Annual Product Quality Review (APQR/PQR), trend analysis, and stability review reports.
- Support Process Validation, Cleaning Validation, Equipment Qualification (IQ/OQ/PQ), and Water System Validation activities.
- Prepare, review, and maintain SOPs, formats, logs, and other quality documents as per QMS requirements.
- Coordinate with Production, QC, Warehouse, and Regulatory teams to ensure compliance with quality standards.
Required Skills
- Knowledge of QMS, GMP, GLP, WHO-GMP, and Schedule M
- Understanding of ALCOA+ principles
- Documentation and SOP preparation
- Internal Audit support
- CAPA, Deviation, and Change Control
- Good communication and documentation skills
- Proficiency in Microsoft Office (Word, Excel, PowerPoint)
Pay: ₹25,000.00 - ₹40,000.00 per month
Benefits:
- Flexible schedule
- Paid sick time
- Provident Fund
Work Location: In person
