Job Title: Assistant Manager – Quality Assurance (QA)
Location: Mahape / Uran, Navi Mumbai
Industry: Pharmaceutical Manufacturing
Experience Required: 5–10 Years
Job Summary
We are seeking an experienced and detail-oriented Quality Assurance professional to support the setup and commissioning of a new pharmaceutical manufacturing facility. The ideal candidate will play a critical role in establishing Quality Management Systems (QMS), ensuring GMP compliance, and driving quality excellence across project and operational phases.
Key Responsibilities
1. Project & Facility Setup
- Participate in the establishment and commissioning of a new manufacturing facility
- Ensure GMP compliance during project planning and execution
- Review facility design, material flow, and process layout from a quality perspective
- Collaborate with Engineering, Production, QC, and Regulatory teams
2. Quality Management System (QMS)
- Develop, implement, and maintain QMS in compliance with GMP requirements
- Prepare and review SOPs, protocols, specifications, and quality documentation
- Ensure robust document control and data integrity practices
3. GMP & Regulatory Compliance
- Ensure adherence to cGMP, WHO-GMP, Schedule M, and other regulatory standards
- Monitor GMP practices across departments
- Support audits, inspections, and regulatory submissions
4. Validation & Qualification
- Review and approve DQ, IQ, OQ, PQ documents
- Coordinate equipment, utility, process, and cleaning validation
- Ensure timely completion of validation activities
5. Quality Operations
- Handle deviations, CAPA, change controls, and risk assessments
- Review batch manufacturing and packaging records
- Ensure compliance with internal quality standards and regulatory requirements
Required Skills
- Strong knowledge of pharmaceutical GMP regulations
- Experience in setting up QA systems for new projects
- Hands-on expertise in QMS, validation, CAPA, and change control
- Excellent documentation and analytical skills
- Strong coordination and leadership abilities
- Proficiency in MS Office and quality systems
Educational Qualification
- B. Pharm / M. Pharm / M.Sc. (Chemistry, Microbiology, Biotechnology, or related field)
Why Join Us?
- Opportunity to work on a greenfield pharmaceutical project
- Exposure to end-to-end plant setup and quality systems implementation
- Collaborative and growth-oriented work environment
Interested candidates can share their updated CV at:
[email protected]
Pay: ₹30,000.00 - ₹50,000.00 per month
Work Location: In person
