Key Responsibilities:

• Implement and maintain QMS activities in the injectables production area.
• Handle deviations, change controls, incidents, and CAPA.
• Review and update SOPs, BMRs, and other controlled documents.
• Ensure compliance with GMP, GDP, and aseptic practices.
• Support qualification and validation activities (IQ/OQ/PQ).
• Monitor documentation practices and ensure data integrity.
• Participate in risk assessments and quality improvement initiatives.
• Assist during internal audits and regulatory inspections (USFDA, WHO, etc.).
• Coordinate with QA, QC, Engineering, and Production teams.
• Ensure proper documentation and record management as per QMS requirements.