Quality Assurance Specialist

CAPA Manager

babeeta.shahi@tcs.com

Key Responsibilities

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. Support internal and external audits by providing evidence of CAPA compliance and effectiveness.

Behavioral Competencies

• Analytical and investigative mindset with keen attention to detail.
• Proactive and outcome-oriented problem solver.
• Strong collaboration skills in a matrixed global environment.
• High adaptability in fast-paced and regulated contexts.

Qualifications & Skills

Category

Requirements

Education

Bachelor’s or Master’s in Life Sciences, Pharmacy, or related field

Experience

4–8 years in pharmacovigilance, quality systems, PVQA, compliance

RCA Methodologies

Strong proficiency in Fishbone, 5‑Whys, FMEA, fault tree tools etc

Regulatory Knowledge

In-depth understanding of EU GVP, ICH, FDA etc

Stakeholder Engagement

Ability to manage cross-functional investigations and drive outcomes

Client Interaction

Experience presenting RCA/CAPA plans to external stakeholders

Project Management

Skilled in planning, tracking, escalations, and verification processes

Communication

Excellent written and verbal skills; able to draft clear CAPA/RCA documents

Software Familiarity

Experience with QMS/CAPA tracking systems; Argus Safety, proficiency in Word, Excel

Audit Support

History of audit support and readiness assurance