Panacea Biotec is a leading research based Health Management Company, with an annual turnover of approx. Rs. 830 Crores. We are engaged in research, development, manufacture & marketing of Vaccines, Bio-Pharmaceuticals and Pharmaceuticals (Rx & OTC) of international quality and Health Services. All Panacea Biotec plants are accredited by international agencies and they follow current Good Manufacturing Practices, as per WHO guidelines.
Post : Executive - Quality Management System
Position description : Handling of Quality Management System activities i.e. Change Control, Deviation, Market Complaints, CAPA, Investigation.
Primary Responsibilities
• Responsible for handling and review of Quality Management system including Change controls, Deviations, Non Conformances, Incidents, investigation and Corrective and Preventive Action.
• Handling of product complaints and ensuring the investigations and closure.
• SAP entry including QA info, BOM Approval, code to code transfer, batch release, sample management.
• Preparation of CAPA response for the regulatory audits, tracking of CAPA response from concerned department, CAPA closure, audit report closure.
• Handling product recall.
• Preparation of Monthly and Quarterly Quality Review for Management review.
• Handling of Out of Specification (OOS), investigation and closer of OOS.
• Handling of Out of Trends (OOT), investigation and closer of OOT.
• Review of Standard Operating Procedure and its compliance.
• To impart training to departmental personnel on own departmental SOPs and cross functional SOPs.
• SAP entry including QA info, BOM Approval, code to code transfer, sample management. & Batch release in SAP.
• Responsible for coordination of training of own department personnel.
• Coordination for activities pertaining to training program.
• Any other job assigned by Head of department.
Educational qualifications preferred
Category : Bachelor's Degree
Field specialization : Pharmacy
Degree : Bachelor of Pharmacy - B Pharma
Industry : Pharmaceutical Injectable plant
Role : QMS
Years of experience : 4 to 6
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