QMS Documentation Officer / Senior Officer - API Production

About the Role

This position is within the Production function of an API pharmaceutical manufacturing setup. The role focuses on managing quality management system documentation for API production, with responsibility for document control, compliance, and coordination across teams.

Role Details

Department: Production – API Pharma

Designation: Officer / Senior Officer

Experience: 5 to 10 years

Qualification: M.Sc. Chemistry or B.E. Chemical

Key Responsibilities

• Create, examine, and manage QMS records used in API manufacturing.
• Work with SOPs, BMR/BPR, formats, logbooks, and protocol documents.
• Ensure all documentation aligns with GMP, cGMP, and applicable regulatory standards.
• Coordinate with QA, Production, and other functions to keep document workflows organized.
• Draft and review deviation reports, change control records, CAPA documents, and incident-related files.
• Maintain orderly storage, archiving, and retrieval of production-related records.
• Provide support during internal assessments, customer audits, and regulatory visits.
• Release and monitor controlled documents as per process requirements.
• Keep documentation logs current and ensure data integrity practices are followed.
• Train production team members on documentation standards and GMP expectations.

Required Skills

The role calls for familiarity with API manufacturing documentation systems, strong knowledge of GMP/cGMP requirements, and hands-on experience with QMS records. Effective communication, interdepartmental coordination, and good command over MS Office and document handling tools are also important.

Preferred Candidate Profile

Candidates with prior exposure to API pharma manufacturing, strong documentation governance knowledge, and the ability to manage multiple documentation tasks independently will be preferred.

Application Note

Interested candidates can send their resume to atull@harmanfinochem.com.

About the Company

Harman Finochem Limited is an India-based pharmaceutical company founded in 1983 by Late Mr. Bhupinder Singh Manhas. The company manufactures and exports active pharmaceutical ingredients such as Metformin HCl, Fenofibrate, Divalproex Sodium, Riboflavin Phosphate Sodium, Glycopyrronium bromide, and others. Its plant is located at Plot No. A/100, Shendra, MIDC, Chhatrapati Sambhajinagar, Maharashtra – 431007.