Debashis Samal

Experience

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  Intas Pharmaceuticals

  Apr 2009 - Jun 2010

  Technology Transfer Officer

  Process development for new immediate release and modified release solid oral dosage to facilitate technology transfer.Plan scale-up and down batches in manufacturing area and oversee the batch executions with the responsible project scientists or mfg team.May lead and/or Collaborates with multidisciplinary teams to resolve complex product / process development issues and respond to internal and external audits.Generate accurate, reliable data by following established procedures and practices. Record, tabulate, summarize, interpret, report and publish study results.Develop and maintain department standard operating procedures.Audit and release of the API Technology transfers to plant locationsSupport to stake holders timely submission / Query response of ANDA, NDA, IND, DMF and India regulatory. Show less

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  Accord Healthcare

  Jun 2010 - Sept 2012

  Technology Transfer Officer

  Support for execution and release of IMP batches to PDR for IMP studies.Review and Audit of Technology transfer documents i.e. Process package, API Lab Development reports, Impurity Characterization Reports, Risk Assessment Reports for drug substance / chemical development are complete, adequate and justified prior to transfer to manufacturing sites.Review of IMP batch manufacturing Records and IMP batches Analytical data. Review of stability data of Lab validation / Development batches.Review of Specifications and test methodsSupport to stake holders timely submission / Query response of ANDA, NDA, IND, DMF and India regulatoryReviewing Deviations/Change control/CAPA and associated Investigation reports prior to release of Technology Transfer documents to Manufacturing site.Reviewing SOPs / Guidelines related to Chemical ResearchMonitoring /support for of DQ Lab for IMP batches manufacturing and Lab compliance.Reviewing facility and equipment qualification documents such as URS, DQ, IQ, OQ & PQ related to Chemical Research. Show less

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  National Health Mission Odisha

  Oct 2012 - Sept 2016

  Regional Vaccine & Cold Chain Manager

  Overall Responsibility:Appropriate vaccine supply and to strengthen the supply chain logistic in the Koraput Region (Koraput, Nawrangpur, Malkangiri & Rayagada). Monitor and supervise vaccine logistic management support for cold chain planning, monitoring, training, and budgeting of region. Yearly EVM assessment of cold chain and vaccine logistic, organizing quarterly review at regional level and annual review of CCT and Vaccine Handlers. Ensure the Phase out plan of CFC equipment in the RVS as well as the districts and to submit the requirement plan of Non-CFC equipment with expansion of ILR Points in the Region. To ensure disposal/auction of condemn cold chain equipment as per CPCB/the Government of India guideline and submit the report to State as and when required. Monitor the immunization programme of the region.Major Responsibility:• To support the SCCO / DD (Immu)/SEPIO for appropriate vaccine supply and to strengthen the supply chain logistic in the regional Districts.• Plan appropriate Vaccine distribution from RVS to respective DVSs and to maintain computerized records of receive and supply from higher to lower level. • Regular visit all cold chain points in every Quarter to assess the gaps of supply chain logistic and to correct the gaps.• Supervise and monitor the field staff ( LHV, MPHS, HW male/female), to give them on job training. • Cold chain planning, monitoring, training, and budgeting of RVS as well as the districts under the region and submit SOE /UC in time (immunization PIP-Part C) & all reports.• Conduct Yearly EVM assessment (WHO-UNICEF) of cold chain and Vaccine Logistic of all cold chain point and plan for gap filling. • Ensure yearly cold chain inventory and to regularly update NCCMIS at regional districts and analyze the data for preparing Vaccine, Logistic and Cold chain management report/Cold Chain reports.• Carry out Quarterly review at Regional Level and Annual Review of CCT and Vaccine Handlers. Show less

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  UNDP in India

  Sept 2016 - Jan 2017

  Consultant

  Overall ResponsibilityUNDP has been implementing automated vaccine and logistics distribution in the districts of odisha under the overall management of Routine Immunisation programme(RI) . The consultant will be responsible for planning, management and oversight the implementation in coordination and consultation with the State/District Vaccine and Cold Chain Management Team.Highlighted Responsibilities• Responsible for implementation of automation in supply chain management for vaccine and UIP logistics with special emphasis on inventory management and distribution from State Vaccine Store to Cold Chain Point level.• Estimate requirements per guidelines and provide support to District Project Management Units in estimating and tracking requirements, and related responsibilities.• Coordinate together with SEPIO, Deputy Director Immunization, CCO in consultation with the SVLM,CCM,RVCCM in the state/ region.• Supervise and guide supply chain management related recording and reporting especially at district and sub district levels.• Provide support in capacitating concerned project personnel, field supervisors and volunteers on all facets of pharmaceutical and health products management. Participate in meetings, consultations, workshops, as necessary.• Carry out field visits to strengthen eVIN implementation including but not limited to, tracking requirement and physical verification of stock at district, sub-district and subcentre levels and take necessary actions. Show less

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  UNICEF

  Jan 2017 - Dec 2017

  Consultant

  RMNCHA Implementation and dash board analysis. Implementation of Automation in Vaccine Supply Chain and Routine Immunisation. Programme. Suggesting the the SEPIO, Deputy Director Immunisation, CCO etc about the EVSM(WHO-Unicef)implementation. Other strengthening measures implementation to increase the Routine Immunisation coverage. .

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  HariRai Pharmaceuticals

  Feb 2018 - now

  Founder