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).
Solid communication and coordination skills.

📌 Officer Production Qa Background Parenteral Manufacturing Mumbai
🏢 Bharat Serums and Vaccines
📍 Mumbai