Job Title: PV CAPA Manager
Location: Mumbai, India
Job Type: Full-Time
Experience Required: 3–8 Years
Apply By: 04 February 2026
Industry: Pharmacovigilance | Medical Regulatory | Business Process Services
Tata Consultancy Services (TCS) is a global leader in IT services, consulting, and business solutions, partnering with life sciences and healthcare organizations worldwide. TCS supports end-to-end pharmacovigilance and regulatory operations with a strong focus on compliance, quality, and continuous improvement.
TCS is hiring an experienced PV CAPA Manager to support pharmacovigilance quality systems and ensure effective Corrective and Preventive Action (CAPA) management. The role involves leading root cause analysis, developing and implementing CAPA plans, ensuring regulatory compliance, and supporting audits and inspections in a global PV environment.
Identify and initiate CAPA triggers arising from audit findings, deviations, quality issues, and regulatory inquiries
Lead structured Root Cause Analysis (RCA) using methodologies such as Fishbone diagrams, 5-Whys, and data-driven analysis
Develop and manage robust CAPA plans with defined ownership, timelines, implementation steps, and effectiveness metrics
Ensure CAPA activities align with EU GVP, ICH guidelines, global regulatory requirements, and internal SOPs
Collaborate with cross-functional teams and sub-teams to ensure comprehensive issue resolution and CAPA coverage
Present RCA findings and CAPA plans during client and stakeholder review meetings; address queries and incorporate feedback
Monitor and track CAPA implementation progress against milestones, escalate delays, and ensure timely execution
Perform CAPA effectiveness checks and ensure accurate documentation for quality review and formal closure
Prepare CAPA metrics, dashboards, and trend analyses to identify recurring issues and recommend process improvements
Maintain inspection-ready documentation and support internal, client, and regulatory audits and inspections
3–8 years of experience in Pharmacovigilance CAPA, Quality Management Systems, or PV Compliance
Strong hands-on experience with CAPA management, RCA, SOP documentation, audits, and inspections
In-depth knowledge of pharmacovigilance regulations, medical regulatory requirements, and quality systems
Experience interacting with clients and regulatory stakeholders
Strong analytical, documentation, and problem-solving skills
Excellent written and verbal communication abilities
Bachelor’s or Master’s degree in Pharmacy or Life Sciences, including:
B.Pharm / M.Pharm
B.Sc / M.Sc
Any Life Sciences graduate with relevant PV CAPA experience
Exposure to global pharmacovigilance environments
Ability to manage multiple CAPAs simultaneously and work in cross-functional teams
Strong understanding of continuous improvement and quality metrics
Opportunity to work with global life sciences clients
Exposure to complex pharmacovigilance compliance and regulatory projects
Structured career growth within a globally recognized organization
SEO & GPT-Optimized Keywords:
PV CAPA Manager Jobs, Pharmacovigilance CAPA Careers, PV Quality Jobs Mumbai, CAPA Pharmacovigilance Roles, Drug Safety Compliance Jobs, TCS Pharmacovigilance Careers, EU GVP CAPA Jobs, Life Sciences Quality Roles
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