Nitin Kohojkar

Experience

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  Sandoz Private Limited

  Jan 1979 - Jan 1999

  Quality Assurance Executive

  Maintenance of quality standard for incoming raw materials, packing materials and finished products and equipment qualificationsWorking on various analytical instruments such as Gas chromatograph, HPLC, Spectrophotometer, Auto-titration, Particle size analyzer, GC Mass, IR, etc. Execute control on release and rejection of materialsMethod development on G.C. HPLC and validations of analytical methods Calibration of various analytical instruments.Packaging development developing the new packs and upgradation of current packsImplementation of Business Planning and control system (BPCS) in the organization for Quality Control DepartmentImplementation of ISO9002 for the organization and efforts are towards continuous improvement of Quality standards Show less

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  Novartis Pharmaceuticals

  Jan 1997 - Jan 1999

  Assistant Quality Assurance Manager

  Maintenance of quality standard for incoming raw materials, packing materials and finished products and equipment qualificationsWorking on various analytical instruments such as Gas chromatograph, HPLC, Spectrophotometer, Auto-titration, Particle size analyzer, GC Mass, IR, etc. Execute control on release and rejection of materialsMethod development on G.C. HPLC and validations of analytical methods Calibration of various analytical instruments.Packaging development developing the new packs and upgradation of current packsImplementation of Business Planning and control system (BPCS) in the organization for Quality Control DepartmentImplementation of ISO9002 for the organization and efforts are towards continuous improvement of Quality standards Show less

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  Neogen Chemicals Limited

  Jan 1999 - Jan 2000

  Quality Assurance Manager

  • Maintenance of cGMP Standards in the organization and manage Quality Assurance and Quality control related activitiesProcess Validations and Equipment validationsAnalytical Method ValidationsExecute control on release and rejection of materialsReview batch manufacturing recordsHandle non-conforming productsHandle customer complaintsForm SOPS and monitor all activities are performed as per written SOPS.Implement document control

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  Calyx Chemicals & Pharmaceuticals Ltd.

  Jan 2000 - Jan 2001

  Quality Assurance Manager

  Maintenance of cGMP Standards in the organization and manage Quality Assurance and Quality control related activitiesProcess Validations and Equipment validationsAnalytical Method ValidationsExecute control on release and rejection of materialsReview batch manufacturing recordsHandle non-conforming productsHandle customer complaintsForm SOPS and monitor all activities are performed as per written SOPS.Implement document control

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  Sun Pharmaceutical Industries Ltd

  Jan 2001 - Jan 2005

  Manager Regulatory Affairs

  Preparation and submission of Drug Master files for US, EDQM, Europe, Canada and various other authorities Provide regulatory updates to respective government agenciesUpdating Drug Master Files and responses on various queries received from regulatory authoritiesEnsure compliance to regulatory requirements and co-ordinate all external audits including USFDA/EU/TGA auditsChecking and approving Specifications, Method Validation Protocols, Process Validation ReportsChecking data on Stability Samples, Working Reference StandardsPreparing registration documents for Russia, Ukraine, Taiwan, Brazil Assist marketing department by providing technical support Show less

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  Ratiopharm

  Jan 2005 - Jan 2008

  Senior Manager Quality Assurance and Regulatory Affairs

  Planning and conducting cGMP audits of Indian API manufacturers and Contract manufacturer on behalf of different ratiopharm group companiesCoordination of Technical Agreements/Contract Manufacturing AgreementsProvide technical support to purchasing and sourcing activities Point of contact for quality and cGMP-related matters in India Plan and coordinate action items in case of quality complaintsProviding regulatory support as a liaison between corporate regulatory department and vendor Show less

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  Sandoz

  Jan 2008 - now

  Deputy General Manager - Senior Global Quality Assurance Auditor

  Planning and performing cGMP audits of external suppliers/contractors from India, China, Japan, Europe, etc.Internal auditing of various Sandoz sites globally and monitoring of follow up activitiesPreparation of audit reports in Trackwise (AQWA) system Performing Pre audits and Technical visits per Sourcing office requirement for Sandoz and NovartisProviding support to Sourcing department of Sandoz and Novartis on technical matters and complaint management Providing Regulatory support as a liaison between different Sandoz sites and vendor Show less

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  Self-employed

  Jan 2017 - now

  PHARMA GMP AUDITOR
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  NITIN KOHOJKAR

  Jan 2019 - now

  Working as Independent GMP Auditor

  Qualified ratiopharm GmbH lead Auditor since 2005 to 2008 and Sandoz (Novartis) lead auditor since 08/2008 to 2017. Worked as external auditor for Novartis Global Audit team till current.Certified Novartis auditor as well as Certified auditor for Europe’s and US leading service provider of accredited GMP audits of API manufacturers (API audits) and excipient manufacturers (excipient audits)700 on-site audit days i.e. 350 companies audited as auditor / lead auditor (EU GMP Part I, EU GMP part II / ICH Q7, EXCiPACT™ Standard, IPEC-PQG GMP guide, during the last 14 years Specialization in Non sterile and sterile API, Non sterile FDF, API starting material, Excipient, Primary packing material audits Show less