PV CAPA Manager (Pharmacovigilance – CAPA & Quality)
Job ID: 385991
Location: Mumbai, Maharashtra, India
Employment Type: Full-Time
Experience Required: 3–8 years
Functional Area: Pharmacovigilance | Quality Management | CAPA
Industry: Life Sciences | Healthcare | IT-Enabled Services
Job Overview
Tata Consultancy Services (TCS) is seeking an experienced PV CAPA Manager to lead Corrective and Preventive Action (CAPA) activities within Pharmacovigilance operations. This role is critical in ensuring regulatory compliance, audit readiness, and continuous quality improvement across global drug safety programs.
The position is ideal for pharmacovigilance professionals with strong expertise in RCA, CAPA lifecycle management, SOP governance, and audit/inspection support.
Key Responsibilities
Issue Detection & CAPA Initiation
Identify triggers for Root Cause Analysis (RCA), including audit findings, deviations, quality issues, and regulatory inquiries.
Ensure timely initiation of CAPA activities in alignment with quality and regulatory expectations.
Root Cause Analysis (RCA)
Lead structured RCA activities using recognized methodologies such as Fishbone (Ishikawa), 5-Whys, and trend analysis.
Collect, analyze, and evaluate relevant data to identify root and contributing causes.
CAPA Planning & Development
Develop comprehensive Corrective and Preventive Action plans with defined ownership, timelines, implementation steps, and effectiveness criteria.
Ensure CAPA alignment with EU GVP, ICH guidelines, global regulatory requirements, and internal SOPs.
Stakeholder Collaboration
Partner with cross-functional teams to ensure full issue visibility and effective CAPA implementation.
Facilitate cross-functional discussions to gather inputs and drive timely execution.
Client & Regulatory Interaction
Present RCA findings and CAPA strategies during client review meetings.
Address stakeholder and regulatory queries, incorporate feedback, and finalize CAPA documentation.
Implementation Tracking & Monitoring
Track CAPA progress against predefined milestones and timelines.
Escalate risks or delays and oversee on-ground verification activities.
Effectiveness Checks & CAPA Closure
Conduct CAPA effectiveness evaluations to confirm issue resolution and prevention of recurrence.
Prepare final CAPA reports, closure documentation, and submit for quality approval.
Reporting & Continuous Improvement
Generate CAPA metrics and trend reports (open CAPAs, aging, recurring issues).
Identify systemic gaps and recommend process and quality improvements.
Audit & Inspection Readiness
Maintain complete, inspection-ready documentation for RCA and CAPA activities.
Support internal audits, client audits, and regulatory inspections with compliant evidence.
Required Skills & Competencies
Strong expertise in Pharmacovigilance CAPA and Quality Management Systems (QMS)
In-depth knowledge of EU GVP, ICH guidelines, and global regulatory standards
Hands-on experience with audit and inspection support
Proficiency in SOP authoring, review, and implementation
Excellent analytical, documentation, and stakeholder management skills
Ability to work independently and manage multiple priorities
Qualifications & Experience
Educational Qualification:
Bachelor of Pharmacy (B.Pharm)
Bachelor of Science (B.Sc)
Master of Pharmacy (M.Pharm)
Master of Science (M.Sc)
Experience:
Minimum 3 years and up to 8 years of relevant experience in Pharmacovigilance CAPA, Quality, or Regulatory Operations.
Role Details
Job Function: Business Process Services
Role Level: Executive
Location: Mumbai, India
Application Deadline: 04 February 2026
Why Join TCS
Opportunity to work on global pharmacovigilance and quality programs
Exposure to regulatory inspections and high-impact CAPA initiatives
Structured career growth within a leading global organization
Strong emphasis on quality, compliance, and continuous improvement
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