Prem Kumar

About Prem Kumar

Experienced in both regulated R&D and Plant working environment Exposure to various regulatory audits including like USFDA, WHO, CDSCO, ANVISA & QP Worked on gap assessment of internal site based on current regulatory requirement and enhances standard operating procedure within site Responsible for preparation GMP document (SOP and Format) Responsible for equipment/instrument qualification and validation of computerized systems (V model)(i.e. URS, GxP assessment, validation plan, Traceability matrix, data integrity) and ensure that the expectation of 21 CFR Part 11 are satisfied implemented Internal Systems Auditor Enough skills for Material Management Experience in Equipment/Instrument/Facility/Utility/Water Qualification Ensures that quality assurance systems e.g. document management, change control system, training, escalation management and risk management are in compliance with local and global requirements Proficiency in software skills Electronic Lab Notebook (eELN) Learning management System (LMS), Documentum Compliance Manager (DCM) Electronic Data Management System (EDMS) Track-wise (For CCR/CAPA/Deviation/OOS/OT) SUMTOTAl, Nichelons (TMS)

Experience

1. Purchasing Manager

   Fresenius Kabi

   Apr 2022 — Present · Gurugram, IN

Education

• Maharshi Dayanand University Rohtak

  Bachelor’s Degree, Industrial and Physical Pharmacy and Cosmetic Sciences, A

  2007 — 2010

• SDPMT college of Pharmacy

  Diploma in Pharmacy, Pharmacy

  2005 — 2007

• Pandit BD Sharma Institute of Medical Sciences

  Master in Pharmacy, Drug Regulatory Affairs

  2017 — 2019