Sathishkumar Natarajan

Results-driven Quality Assurance leader with 19+ years of progressive experience in pharmaceutical and chemical manufacturing. Deep expertise in cGMP compliance, regulatory audit management, CAPA systems, deviation investigations, and quality systems governance across USFDA, EU-GMP, and COFEPRIS regulated environments. Proven track record of maintaining zero critical observations in regulatory inspections, building robust QMS frameworks, and leading cross-functional teams to deliver consistent quality outcomes.

Adept at driving continuous improvement and embedding a quality culture across all levels of manufacturing operations. Currently based in Dubai, seeking a senior QA leadership role.

Technical Service Manager (QA & Process Support) - TANFAC Industries Ltd. - Cuddalore, TN | Relocated to Dubai: March 2026

(2025-05 - 2025-08)

• Provided quality and technical assurance support to Production, QA, and Engineering, improving process compliance and cross-functional coordination.
• Led risk assessments and feasibility studies for new product introductions, ensuring QA sign-off on all scale-up and technology transfer activities.
• Conducted process investigations and deviation analyses; implemented corrective actions to restore GMP compliance and prevent recurrence.
• Evaluated equipment and technologies for new projects with a focus on qualification requirements and regulatory readiness.

Senior Manager – Quality Assurance & Production - Global Pharma Healthcare Pvt. Ltd. - Cheyyar, TN

(2024-02 - 2025-05)

• Oversaw end-to-end QA compliance for API manufacturing operations, including batch release, deviation management, and regulatory submissions.
• Led deviation investigations and CAPA implementation in coordination with QA/QC and Regulatory Affairs teams, resolving compliance gaps effectively.
• Ensured continuous audit readiness through rigorous SOP compliance, documentation control, and internal self-inspection programs.
• Managed change control processes; reviewed and approved BMRs, manufacturing changes, and batch documentation for regulatory compliance.
• Supported external regulatory audits and client audits; coordinated audit response activities and CAPA closure tracking.

Assistant Manager – Quality & Project Management - Nuray Chemicals Ltd. - Tiruvallur, Chennai

(2022-07 - 2024-01)

• Ensured quality and compliance milestones were embedded into plant project timelines and deliverables from initiation through commissioning.
• Coordinated regulatory and GMP compliance activities across cross-functional teams; managed stakeholder communication on quality-related risks.
• Monitored project quality KPIs and reported compliance status to senior management; implemented risk mitigation strategies for quality risks.

Assistant Manager – Process Engineering & QA Support - Sai Life Sciences Ltd. - Hyderabad

(2019-11 - 2022-06)

• Conducted shop-floor investigations, root cause analysis, and troubleshooting for process deviations and quality events in API manufacturing.
• Reviewed BPRs, ECRs, validation protocols, and campaign reports for GMP compliance and data accuracy; provided QA approval sign-off.
• Supported CAPA implementation and worked closely with QA teams on deviation investigation documentation and effectiveness checks.
• Led cross-functional continuous improvement initiatives aimed at reducing deviations, improving yield consistency, and strengthening quality systems.

Assistant Manager – Production Head & QA Lead - SPC Life Sciences Pvt. Ltd. - Ankleshwar, Gujarat

(2017-11 - 2019-11)

• Managed BMR/ECR reviews, deviations, CAPA, and change control as the QA accountable lead for the production site.
• Trained and mentored production staff on cGMP, SOP compliance, and quality culture; conducted regular GMP refresher programs.
• Ensured environmental and safety compliance; maintained site quality metrics and participated in internal quality audits.
• Drove Operational Excellence project achieving measurable improvements in compliance adherence, cycle time, and quality yield.

Executive → Officer-I → Officer-II (QA & Production) - Sun Pharmaceutical Industries Ltd. - Karunguzhi, TN | 9-Year Progressive Career

(2008-11 - 2017-11)

• Managed QA compliance activities including deviation management, CAPA, change control, and regulatory audit support across all production batches.
• Successfully supported USFDA, EU-GMP, and COFEPRIS inspections — maintained zero critical findings through rigorous documentation and system controls.
• Authored, reviewed, and maintained SOPs, BMRs, and validation documents; coordinated equipment qualification and compliance activities site-wide.
• Championed Operational Excellence QA initiatives at Ahmednagar (Gujarat) and Chennai, delivering sustained improvements in quality KPIs and productivity.

Production Engineer - Indfrag Ltd. - Hosur, TN

(2007-09 - 2008-11)

• Supervised batch production with a focus on product quality assurance, process standardisation, and inventory compliance audits.

Production Engineer - Tagros Chemicals (I) Ltd. - Cuddalore, TN

(2005-09 - 2007-09)

• Managed batch operations and daily process monitoring; upheld quality standards and safety protocol adherence across chemical manufacturing activities.

MBA - Human Resources - Madras University

B.Tech - Chemical Engineering - Anna University – Arunai Engineering College Tiruvannamalai