Pv Capa (Maharashtra)

TCS is hiring for CAPA Manager Job Location - Mumbai Experience Range - 3 to 8 Years Skillset Required - CAPA with Pharmacovigilance SOP documents audit inspections Educational Qualification s Required - Any Life Science Graduate Roles Responsibility Issue Detection Initiation - Identify triggers for RCA such as audit findings issues deviations and regulatory inquiries Root Cause Analysis RCA - Lead structured RCA efforts using tools such as Fishbone diagrams 5-Whys etc Compile and analyze all relevant data to uncover root and contributing factors CAPA Planning Development - Draft robust corrective and preventive action CAPA plans with transparent ownership timelines implementation steps and verification metrics Ensure CAPA plans align with EU GVP ICH guidelines regulatory guidelines internal SOPs Stakeholder Engagement - Collaborate across functions sub-teams to ensure full root cause visibility and comprehensive CAPA coverage Facilitate cross-functional meetings to gather input and coordinate implementation activities Client Regulatory Interface - Present RCA findings and CAPA proposals during client review calls Address queries incorporate feedback and finalize CAPA plans with stakeholders and clients to ensure stakeholder alignment and acceptance Implementation Tracking Monitoring - Oversee timely execution of CAPA plans ensuring tasks are completed as per timeline Track progress against predefined milestones escalate delays and manage on-ground verification activities Effectiveness Follow up CAPA Closure - Conduct effectiveness checks to confirm CAPA has resolved the issue and prevented recurrence Compile final CAPA reports complete closure documentation and submit for quality approval before official closure Reporting Continuous Improvement - Generate regular CAPA metrics and trending reports e g open CAPAs aging recurring issues Use trend analyses to identify systemic weaknesses and recommend process improvements Audit and Inspection Preparation Compliance - Maintain comprehensive inspection-ready documentation related to RCA and CAPA activities Support internal and external audits by providing evidence of CAPA compliance and effectiveness Location Mumbai Job Function BUSINESS PROCESS SERVICES Role Executive Job Id 385991 Desired Skills Medical Regulatory Desired Candidate Profile Qualifications BACHELOR OF PHARMACY BACHELOR OF SCIENCE B Sc Degree MASTER OF PHARMACY MASTER OF SCIENCE