PV CAPA

TCS is hiring for PV CAPA Role!!! Experience Range – 4 to 6 Years Skillset Required - CAPA with Pharmacovigilance, SOP documents, audit & inspections and deviation handling are must required skills. Educational Qualification(s) Required – Any Life Science Graduate Location - Mumbai Roles & Responsibilities:-

• Knowledge and expertise in pharmacovigilance, audit CAPA and Deviation handling is a must.
• Collaborate with client departments/teams internal and external to provide oversight and ensure proper development of CAPAs from internal quality audits and regulatory inspections, as assigned by respective stakeholder.
• Support stakeholder for the development of responses to Audit, Regulatory Inspection or Process Deviation observations.
• Set up and coordinate the required meetings in order to expedite the CAPA preparation and closure process.
• Ensure timely and effective closure of assigned CAPAs in collaboration with the Finding and CAPA Owners.
• Track and monitor CAPAs with assigned stakeholders.
• Ensure CAPA effectiveness checks, where applicable.
• Creation of metrics/slide decks at agreed upon intervals to help visualize progress and challenges and perform trend analysis if required.
• Monitor due dates ensuring timely & effective closure of deviation & its associated CA-PAs and, when required, support development of suitable extension or modification to agreed CAPA plan.
• Track and assess CAPA effectiveness checks completion, where applicable.