Scope –

This role is responsible for handling Quality ManagementSystem and driving the compliance for Pilot Plant under Formulation BusinessUnit.

Key Technical Strengths:

• Quality ManagementSystem
• Review Activities
• Data ManagementActivities
• Experience of facingUSFDA, MHRA, ANVISA etc. directly (preferably as QA head)
• Digitalisation & Automation
• Well versed with relevantsoftware like LIMS, QMS, SAP etc

• Responsibilities – 1.       Developing, implementing, and maintaining the Quality Management System and monitoring of its effectiveness. 2.       Responsible to ensure issuance and control of Standard Operating Procedures, maintenance of the Site Master File. 3.       Monitoring day to day activities of assigned jobs to the team and providing inputs to resolve the discrepancies in order to maintain appropriate quality systems 4.       Responsible to conduct self-inspections and external audits as appropriate. 5.       Responsible to provide direct support during customer and regulatory audits 6.       Responsible to conducting vendor audits. 7.       Responsible for provide training in all aspects of Quality Management Systems and GMP including procedural updates. 8.       Responsible to Handling and closure of Quality Notifications 9.       Responsible for review of suitability, implementation, monitoring and review of effectiveness of corrective and preventive actions. 10.   Responsible for supporting quality related customer complaint investigations and trending activities  11.   Responsible for review and approval of Customer Technical/Quality Agreements 12.   Handling of Management Review Meetings 13.   Responsible for review and approval of Quality related documents 14.   Responsible for support and maintain Business Continuity Management Plans 15.   Responsibility to ensure that the integrity of the management system is maintained when changes to the management system are planned and implemented. 16.   Responsible for approval of Analytical methods, validation documentation 17.   Responsible for approval and release of Certificate of Analysis (CoA) 18.   Responsible for Document control (records storage are secured to protect confidentiality under restricted access control to authorized personnel). 19.   Interacts with Site Head for getting resources need and departures from management system procedures, non-conformities. 20.   Managing the Empower software as a QA admin.  Required Educational Qualification & Relevant experience Post Graduate (Analytical Chemistry/Organic Chemistry or equivalent) M. Pharm with 12-15 yrs of relevant experience