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3 weeks ago

Palghar, India NuVvaGen Bioscience P. Ltd. Full time

To ensure compliance with GMP, regulatory standards, and internal quality systems by executing quality assurance activities including documentation control, batch review, audits, validations, and training.

**Key Responsibilities**:

- Review and approve batch manufacturing records (BMRs), batch packaging records (BPRs), and associated quality documents.
- Monitor and ensure compliance with cGMP and regulatory requirements.
- Handle deviations, change controls, CAPAs, and risk assessments.
- Participate in internal and external audits (regulatory and client).
- Manage and control SOPs, protocols, and other controlled documents.
- Conduct training programs on quality systems and GMP for production and QA personnel.
- Review and support qualification/validation protocols (equipment, process, cleaning, etc.).
- Ensure timely closure of non-conformances and audit observations.
- Sampling and review of raw materials, packaging materials, and in-process samples if required.
- Coordinate with cross-functional teams for continuous improvement in quality systems.
- Support in regulatory inspections and customer audits.

**Required Qualifications & Skills**:

- B.Pharm / M.Pharm / M.Sc in a relevant discipline.
- 2-5 years of QA experience in the pharmaceutical industry.
- Good knowledge of GMP, GLP, and regulatory guidelines (USFDA, MHRA, WHO, etc.).
- Strong documentation and communication skills.
- Attention to detail and a proactive approach.
- Proficient in MS Office and electronic documentation systems.

Pay: ₹15,000.00 - ₹25,000.00 per month

**Benefits**:

- Provident Fund

Schedule:

- Day shift

Work Location: In person