G. Kumaresan

Deputy General Manager @Natco Pharma

Chennai, IN

Industry : Bulk drug Manufacturing (Generics)Specialization : Department Head - QC (At present supporting to QA activities also; Job Responsibilities-Ensure effective functioning of the department activities.Manpower planning for regular shift activitiesAssigning job responsibilities to overall QC persons.Ensuring Quality of Raw materials, intermediates and finished products.Ensuring proper investigation of deviations, complaints, stability failures and out of specifications.Review and Training with respect to GMP, GLP, Protocols, SOPs, STPs and SPECs.Evaluation for production related SOPs, BPCRs and BCRs.Ensuring lab compliance in overall QC activities.Coordination with QA to prepare site master file, process, drying, cleaning validation protocol and report.Conducting self-inspection audit for production areas & stores.Review of QA and QC-Microbiology related documents.Coordination with QA for new document initiation, deviation, change control, vendor audit and OOS investigation.Customer and regulatory audit preparation.General lab compliance, Document review & release and Facing internal and external audits, OOS investigation.

XII Standard - Higher Secondary/Junior College

Physics; Chemistry, Maths, Biology

MS University

Master of Business Administration (MBA)

VELS University

M.Phil

National Hr. Sec.School

+2

University of Madras

Bachelor of Science (B.Sc)

Annamalai University

Master of Science (M.Sc)

Islamiah college

B.Sc