Mohan Kumar Muthusami

Pharmaceutical QA professional with 6+ years of experience in aseptic processing, sterility assurance, and GMP-compliant manufacturing environments. Strong expertise in contamination control strategy, microbial trend analysis, and audit readiness aligned with USFDA and EMA standards. Demonstrated success in maintaining aseptic compliance, reducing contamination risks, and supporting regulatory inspections with zero major observations.

Experienced in risk assessment using FMEA and driving continuous improvement initiatives in sterile manufacturing. Seeking QA roles in Pharmacovigilance/ Clinical trial data management.

Senior Executive at Somerset Therapeutic Private limited (2024-04 – Present)

• Leads Media Fill (aseptic process simulation) studies by planning, executing, and documenting runs in line with regulatory requirements, ensuring successful validation outcomes.
• Manages operator qualification and requalification programs including gowning assessments and aseptic technique evaluations, improving compliance across sterile areas.
• Performs routine aseptic surveillance during manufacturing operations, identifying deviations and reinforcing validated practices to maintain contamination control.
• Delivers structured training on aseptic behaviour, gowning procedures, and contamination control, strengthening operator adherence and audit readiness.
• Leads USFDA audit preparation and internal audits, identifying and resolving 10+ compliance gaps, achieving zero major observations, and supporting updates to site-wide contamination control strategy (CCS).

Executive at Biocon Biologics Limited (2022-08 – 2024-04)

• Executed load development studies for steam sterilizers, optimizing cycle parameters for multiple equipment and product configurations.
• Presented sterilization validation protocols during EMA audit, supporting successful qualification with no critical observations.
• Performed bi-annual re-qualification of sterilizers aligned with GMP and EMA regulatory requirements.
• Delivered structured training programs for operators and contract staff, improving compliance and operational efficiency.
• Conducted monthly facility audits across aseptic and non-aseptic areas ensuring adherence to GMP and contamination control standards

Associate at Mylan Laboratories Ltd (2019-10 – 2022-07)

• Operated serialization and aggregation systems ensuring compliance with global traceability standards across injectable products.
• Prepared and approved master labels for 10+ injectable products supporting US and Australia regulatory markets.
• Led packing operations managing a team of 60 operators, ensuring efficiency and adherence to GMP standards.
• Reviewed 80+ BMR/BPR documents monthly to maintain audit readiness and ensure process compliance.
• Executed equipment and area clearance for inspection processes including X-ray, leak testing, AQL, and visual inspection using validated SOPs

Master of Pharmacy in Pharmacology – JKKN College of Pharmacy (2022 – 2024)

Bachelor of Pharmacy – JKKN College of Pharmacy (2015 – 2019)