PV CAPA(TCS)

Roles and Responsibilities

Job Description

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

1. Issue Detection & Initiation - Identify triggers for RCA such as audit findings, issues/deviations, and regulatory inquiries.

2. 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.

3. CAPA Planning & Development - Draft robust corrective and preventive action (CAPA) plans with clear ownership, timelines, implementation steps, and verification metrics. Ensure CAPA plans align with EU GVP, ICH guidelines, regulatory guidelines internal SOPs.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. Audit and Inspection Preparation & Compliance - Maintain comprehensive, inspection-ready documentation related to RCA and CAPA activities.