Debashish Roy is Head - Quality Management at Fresenius Kabi India. He deals with total quality management system and has experience in analytical as well as microbiological lab.
- Conduct self-Inspection that regularly appraises the effectiveness and applicability of Q.A. system.
- Managing & approval of corrective and preventive actions (CAPAs).
- Part of the tem of risk analysis approach.
- Conduct vendor evaluation and qualification.
- Part of the cGMP compliance team to maintenance & access the compliance level in quality management system.
- Involve in handling of market complaints, failure investigations, change controls and deviation management
- Management of microbiology laboratory / clean rooms / Isolator facilities.
- Literature survey for technical and regulatory compliance support to validation and analytical activities.
- Development and review of cGMP compliance related documents like SOPs, STPs, standards, specification, validation protocols, summary reports, reporting formats and checklists.
- Administration of cGMP training and evaluation programs.
- Hosting of regulatory inspectors, foreign delegates, auditors and GMP consultants.
- Involve in preparation of site master file (SMF), validation master plan (VMP), calibration master plan (CMP) and drug master file (DMF), Audit compliance report and product review report (APR).
- Involve in organize qualification, preventive maintenance, calibration, 21 CFR PART 11 compliance in the instruments and failure mode & effect analysis (risk analysis/ risk assessment) of various laboratory / processing equipments (Validation Plan, URS, DQ, IQ, OQ and PQ) and other validation activities like.