Sasikumar Rajaram

Experienced Validation Professional with a demonstrated history of working in the Pharma and Biopharma industry skilled in commissioning, Qualification (IQ/OQ/PQ/), Validation (Process / CSV / Cleaning), Supplier Management, Technology Transfer, New product introduction (NPI), scale up, Deviation Management, Change Control, CAPA, Risk Management and other Quality Management System (QMS).

• Possess knowledge in Regulatory requirements and Codes & Standards (FDA, EMA, GxP, GAMP 5, 21 CFR Part 11, ICHQ7 and PIC/S).
• Knowledge and experience in handling problem-solving tools (e.g. 6M Analysis, Fishbone, 5 Whys, etc.).
• Expertise in commissioning, Qualification and Validation of process equipment
• Experience in handling Internal Quality Audits, Global Quality Audits, FDA, EMA, HSA and other external audits and Compliance.
• Expertise in Cleaning (CIP) Validation, CHT and DHT studies of process equipment
• Expertise in preparation and execution of IOQ / PQ / CTS and protocols
• Implementation and execution of MES in process to improve efficiency and accuracy
• Experience in executing SAP transactions and handling deviations through TrackWise

Master’s Degree in Quality Management (M.Sc.)

Sikkim Manipal University of Health, Medical and Technological Sciences

Bachelor's Degree in Chemistry (B.Sc.)

University of Madras