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
Positive communication and documentation skills
Proficiency in Microsoft Office (Word, Excel, PowerPoint)

Pay: ₹25,000.00 - ₹40,000.00 per month

Advantages:
Versatile schedule
Paid sick time
Provident Fund

Work Location: In person

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