Opening in Topical QMS at Zydus Sikkim

• Develop, review, and update SOPs.
• Investigate deviations, non-conformances, and product quality issues to identify root causes and implement corrective and preventive actions.
• Checking calibration / preventive maintenance status of equipment's and coordinates with engineering department for further activity.
• To interact with internal & external auditor and provide appropriate answer for the query raised by auditor.
• Training of subordinate and operators as per training plan or as on when required.
• Prepare and present reports on QMS performance related to ointments, including CAPA status, investigation outcomes, and compliance metrics.
• Maintain accurate and up-to-date records of SOPs, CAPA reports, investigation findings, and compliance documentation.
• Monitor changes in regulations and update QMS processes and documentation accordingly.
• Track and monitor the effectiveness of CAPA implementations and ensure timely closure of CAPA reports.

• Experience with specific regulations and guidelines related to the manufacture of topical products (e.g., FDA 21 CFR Part 210/211).
• Familiarity with additional quality management tools and methodologies (e.g., Six Sigma, Lean).
• Experience in leading or participating in regulatory audits and inspections.

Zydus