Amrish Kumar Singh Email & Phone Number

Visakhapatnam, Ap, In

Hightstown, New Jersey, Us

Leading the QA team

Taizhou, Jiangsu, Cn

Leading the quality system

Hyderabad, In

Handling of National and International Oncology Manufacturing Projects (Corporate Validation).Handling and Conducting Plant audit and compliance. Implementation of current approach for validation.To Conduct training to enhance the technical skill of technical professionals.Ensure the current GMP adherence in plant with respect to regulatory expectation. Implementation of Risk Base Approach, Integrated Equipment's qualification, Failure mode validation and QbD approach and data integrity.Effective training and development of working staff at regular intervals to apprise them of the latest changes in regulatory requirements, introduction of new technical concepts and to refresh their knowledge about technical or safety aspects of their job.

Bridgewater, New Jersey, Us

Responsible for QMS (CC, CAPA, OOS, OOT, OOL, Deviation and Root Cause Investigation evaluation and closure.Handling of the Calibration, Qualification (DQ, FAT, SAT, IQ, OQ, PQ) Activities, and Preparation of the monthly planner and the Calibration, Qualification Calendar.Validation of HVAC, Water ,Pure Steam, System, Sterilization(Autoclave), PLC ,Computer system, Process Validation of Oncology products (Injectable)Preparation of Vendor qualification protocol, questionnaire and Vendor qualification, and evaluation on account of updated regulatory requirements.Review and Approval of master document viz., SMF, VMP, SOP, Manuals, MFR, MPP, BMR, BPR, Validation Protocol/Report and General Study Protocols.Conduct site audit for RM, PM, Contract Laboratory and Machine, Equipment, Instrument manufacturer /supplier.

Ahmedabad, Gujarat, In

Preparation and review of master document viz., SMF, VMP, SOP, Manuals, MFR, MPP, BMR, BPR.Preparation and review of Validation Protocol/Report and General Study Protocols.Implementation of Risk Base Approach, Integrated Equipments qualification, Failure mode validation and QBD approach data integrity.Responsible for Quality Audit and their compliance Internal & External (as per C GMP,US FDA, MHRA, TGA, ISO-QMS,EMS,GCC,MCC,KFDA,ANVISA,INVIMA,NAM) SAT ,FAT.SAPR.• Validation of HVAC, Water ,Pure Steam, System, Sterilization(Autoclave), PLC ,Computer system, Process Validation for Tablet ,Capsule, Oralliquid,Semisolid, Parentral & Otics (e.g. Drying,Mixing,Filling, Cleaning process) qualification of Area, DQ,IQ,OQ,PQ Of Machine, Equipments and instrument. Handling products complain and recall, CCN, OOS, OOT, CAPA, Deviations management and implementation of cGMP, GLP, GDP. Preparation of Vendor qualification protocol, questionnaire and Vendor qualification, and evaluation on account of updated regulatory requirements.Conduct site audit for RM, PM, Contract Laboratory and Machine, Equipment, Instrument manufacturer /supplier. Effective training and development of working staff at regular intervals to apprise them of the latest changes in regulatory requirements, introduction of new technical concepts and to refresh their knowledge about technical or safety aspects of their job.

Np

Responsible for Quality Audit Internal & External (as per ISO/cGMP), Validation & Qualification, Analytical & Documentation work, Responsible for implementation of cGMP / ISO QMS & EMS.Preparation & review of all kind of master document eg.MFR, MPP, BMR, BPR, SMF, VMP, SOP and in process product compliance SAPR etc