Sarghunan Pasupathi

Manage daily production operation of aseptic pharmaceuticals in a highly regulated facility (USFDA, EMA, NPRA, Anvisa, ISO 9001).

 Production planning and shopfloor execution of insulin production to various markets around the globe.

 Ensure manufacturing and packing activities of Production Drug Product in a high volume and high headcount department are performed in accordance to Good Manufacturing Practices (GMP) and in compliance with relevant SOPs.

 Handle documentation practices such as Product/Material Complaints, deviations, incident reporting (OOS/OOT), Risk Assessment, Change Controls, Qualifications, Product

Performance Verification (PPV), Annual Product Review (APR) and CAPA tracking.

 Review GMP documents such as SOP, protocols, employee certification, reports, trend data and validation/qualification reports.

 Ensure appropriate Root Cause and CAPA are assigned to the issues.

Effectively manage production of pharmaceutical products and consistent deliverance of desired output, meeting customer and marketing demands. Manage department headcounts, financial budgeting, CAPEX projections and inventory management. Successfully and continuously meet corporate goals and KPIs.

Bachelor of Pharmacy (Hons)