Role & responsibilities

- Handling e-QMS related activities and documentation.
- Managing LMS training compliance activities.
- Maintaining DMS documentation, version control, and approvals.
- Initiating and managing Change Controls.
- Investigating and closing CAPA within defined timelines.
- Deviation handling, root cause analysis, risk assessment, and closure.
- Ensuring compliance with cGMP, GDP, and regulatory requirements.
- Supporting internal, external, customer, and regulatory audits.
- Coordinating with QA, QC, Engineering, and Regulatory teams for compliance activities.

Preferred candidate profile

- Exposure to Sterile / Aseptic Manufacturing.
- Regulatory inspection and audit handling experience.
- Knowledge of Quality Risk Management (QRM) and FMEA.
- Experience in APQR / Annual Product Quality Review activities.
- Knowledge of e-QMS, LMS, DMS, Change Control, CAPA, Deviations, and PQR.
- Understanding of USFDA, MHRA, WHO-GMP guidelines.
- Good Documentation Practices (GDP).
- Solid communication and coordination skills.

📌 Officer - Production (QA Background) | Parenteral Manufacturing (Mumbai)
🏢 Bharat Serums and Vaccines
📍 Mumbai