TCS is hiring for CAPA ManagerInterested can share CV on babeeta.shahi@Key Responsibilities- 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 clear 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.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 & SkillsCategoryRequirementsEducationBachelor's or Master's in Life Sciences, Pharmacy, or related fieldExperience4–8 years in pharmacovigilance, quality systems, PVQA, complianceRCA MethodologiesStrong proficiency in Fishbone, 5‐Whys, FMEA, fault tree tools etcRegulatory KnowledgeIn-depth understanding of EU GVP, ICH, FDA etcStakeholder EngagementAbility to manage cross-functional investigations and drive outcomesClient InteractionExperience presenting RCA/CAPA plans to external stakeholdersProject ManagementSkilled in planning, tracking, escalations, and verification processesCommunicationExcellent written and verbal skills; able to draft clear CAPA/RCA documentsSoftware FamiliarityExperience with QMS/CAPA tracking systems; Argus Safety, proficiency in Word, ExcelAudit SupportHistory of audit support and readiness assurance
Job Title
Quality Assurance Specialist