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.

- Positive Documentation Practices (GDP).

- Strong communication and coordination skills.

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