Skills: SOPs, CAPA, FDA 21 CFR Part 210, FDA 21 CFR Part 211, Six Sigma, Lean
Job Description
Designation : Assistant Manager / Senior Executive Role : QMS Reports to : Senior Manager Department : Topical (Ointment) Location : Zydus, Sikkim Qualification : B. Pharma / M. Pharma Years of Experience : 06 to 12 years Job Profile: 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.
Preferred Skills:
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.