Senior Manager- R&D Quality (PV-QA)

• Responsible for Implementation of well-defined documented Quality Assurance programme in line
  with applicable regional/global regulatory requirements/obligations, SOPs and SPIL policies & procedures.
• Assist in developing global Pharmacovigilance auditing program and responsible for conducting and reporting audits being a lead auditor/co-auditor for Sun Pharma sites associate with Pharmacovigilance activities/ operations to assure adequacy & adherence with established Quality Systems.
• Assist in developing global Pharmacovigilance system auditing program and responsible for conducting and reporting audits being a lead auditor/co-auditor for outsourced parties (CROs, Service Providers, Vendors), Affiliates & Partners etc., associated with Sun Pharma Pharmacovigilance operations.
• Management of Internal Audit Observation Database (IAOD) with the perspective of sharing audit reports, CAPA reports and observation of global impact with all internal regional PV sites across the globe and Global Pharmacovigilance.
• Responsible to provide inputs for the preparation and submission of monthly report of GPvP QA to the R&D Quality head
• Conduct periodic Quality review board meetings for PV function
• Responsible for review of Pharmacovigilance SOPs for completeness, clarity, and compliance to global/regional policies, and applicable regulatory regulations & guidelines.
  To prepare and review departmental SOPs
• Conducting Pharmacovigilance procedural trainings within Pharmacovigilance QA group and to operation team on procedures developed by QA.
• Assure all-time readiness at Sun Pharma PV sites globally for regulatory agency/partner inspections, and implementation of appropriate Corrective and Preventive Actions (CAPA).
• Responsible to ensure GxP Computerized Systems at R&D Gurugram (PVG) site are in compliance with the current regulatory standards inline to in house standards.
• Act as PQL (Process Quality Lead) for Validation of computerized systems at R&D Gurugram (PVG) 

• Around 15 years of experience
• Experience handling Pharmacovigilance activities, QA of PV activities
• Experience handling Computer System Validation, Ensuring GxP compliance of computerised systems
  
  

Post Graduate in Pharmacy (M. Pharma) / Pharmacology
Around 15 years of experience