Sanjit Kumar Sahu

Experience

• 

  MKCG Medical College, Berhampur

  Mar 2022 - Apr 2022

  Pharmacist
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  MACLEODS PHARMACEUTICALS LTD.

  Aug 2022 - Sept 2022

  Formulation Production Officer
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  Hetero

  Nov 2022 - now

  Quality Assurance Junior Officer

  Working in Instrument/Equipment Qualification section . Roles- • Involve in Vendor hardware and software qualification activities like execution, review of Qualification documents like User Requirements Specification (URS), Design Qualification (DQ) , Vendor documents and giving GDP Training to vendors at site.• Preparing of In-house Qualification protocols like Validation Plan, Installation and Operational Qualification protocol cum Report, Performance Qualification Protocol, Performance Qualification Report, Validation Summary Report and Requirements Traceability Matrix.• Preparing Risk Assessment based on criticality parameters of respective equipment ,handling and ensuring the compliance of CAPA.• Involve in various types of customer and regulatory audits. Regulatory audits exposed : ZaZiBoNa (Zambia, Zimbabwe, Botswana, Namibia), MCC/SAPHRA (South Africa), INFRAMED (Portugal).• Ensuring compliance as per requirement of cGMP at plant. Show less