S Vinayaka Moorthy

Senior Quality & Regulatory Professional with 20+ years of experience in API and Formulation industries, specializing in Quality Assurance, Analytical R&D, Quality Control, and Regulatory Affairs. Proven expertise in cGMP, WHO-GMP, and USFDA compliance, DMF submissions (eCTD), audit management, and quality system implementation. Strong leader with hands-on experience in building laboratories, managing cross-functional teams, and driving regulatory excellence.

Manager – QA/RA - Proventus Life Sciences Pvt. Ltd. - Maraimalai Nagar, Tamil Nadu

(2025-07)

• Head QA & RA functions ensuring full GMP compliance.
• Manage regulatory documentation including DMF review and submissions.
• Lead GMP certification initiatives and customer audit readiness.
• Review MBMR, BMR, analytical reports, and quality documents.
• Oversee OOS/OOT investigations, deviations, and CAPA implementation.
• Drive continuous improvement across QA, QC, Production, and AR&D.

Manager – QA (Head – QA/QC/AR&D/RA) - Sai Supreme Chemicals - SIPCOT, Gummidipoondi

(2020-08 - 2025-06)

• Led end-to-end Quality and Regulatory operations for the API division.
• Successfully achieved WHO-GMP and MHRA CEP certifications.
• Coordinated DMF submissions in eCTD format to MHRA and CEP authorities.
• Managed Analytical Method Validation, Transfer, and Equivalency Studies.
• Oversaw APQR, Change Control, Deviation, Complaint, and CAPA systems.

Sr. Executive – Analytical R&D - Caplin Point Laboratories Ltd. - Gummidipoondi & TICEL Bio Park, Chennai

(2016-07 - 2020-04)

• Executed Analytical Method Development, Validation & Transfer.
• Specialized in GC Headspace analysis for residual solvents.
• Conducted Cleaning Validation studies.
• Reviewed validation reports and stability data.
• Trained AR&D team members on analytical techniques.

Executive – QA (QC & QA) - Anjan Drug Pvt. Ltd. - USFDA Approved API Unit

(2006-11 - 2016-06)

• Supported USFDA audit readiness and compliance activities.
• Conducted stability, process validation & cleaning validation analysis.
• Managed OOS/OOT investigations and CAPA implementation.
• Performed calibration & troubleshooting of HPLC, GC, UV & IR.
• Prepared DMF documentation, MBMR, BMR & APQR.
• Maintained GLP-compliant laboratory systems.

Senior Chemist – AR&D/QC - Fischer Chemic Ltd. (Now Nuray Chemicals) - Chennai

(2005-03 - 2006-10)

• Performed analytical testing for all Lab chemicals & API intermediates.
• Implemented GDP & GLP systems.
• Managed calibration & preventive maintenance logs.

Chemist – Quality Control - Caplin Point Laboratories Ltd. - Chennai

(2003-09 - 2005-02)

• Conducted raw materials, in-process & finished product testing.
• Maintained documentation & data integrity compliance.

M.Sc. - Chemistry - Annamalai University (2010)

B.Sc. - Chemistry - Sir Theagaraya College, University of Madras (2000)