Pradeep Brahma

Experience

• 

  Alliance Computer Telephony

  Sept 2004 - Jul 2006

  Test Engineer

  Working with a product based Leading Telecom MNC customer.

• 

  Infosys

  Jul 2006 - Aug 2007

  Test Engineer

  Working with Leading Telecom MNC customer.

• 

  HCLTech

  Sept 2007 - Mar 2022

  Over view--Currently working with Cancer diagnostics oncologists, Biobanking and Life Sciences customer.-Understanding the unique needs of the Clinical/Pharma Diagnostics and Prognostics solution.(Oncology)-Collaborate with engineers to provide efficient / cost effective software configuration designs to meet customer expectations.-Gathering and documenting requirements from scientific teams, project teams and other stake holders for a client configuration.-Working on clinical Lab requirement,configuration and functional solution design with development and validation teams.-Providing validation support, UAT testing, IQ,OQ,PQ process in adherence to CSV, 21 CFR-11,HIPAA.-Involved in software pre-sales technical support for sales in the Laboratory Information Management Systems (LIMS) software industry.-Assist with functional RFP processes as a member of HCL Life science COE ( center of excellence ).Domain Area:-Clinical/Pharma Diagnostics Laboratory (Oncology) including below modalities: Molecular: SANGER & NGS. Immunohistochemistry (IHC): Fluorescent In-situ Hybridization (FISH). FLOW Cytometry.-Involved in end to end flow of lab automation beginning from accessioning, histology( Grossing > processing >embedding > Microtomy) & Lab specific workflow to reporting & Analytics. Show less

  • Associate Business Manager

    Mar 2016 - Mar 2022

  • Business Analyst

    Sept 2012 - Mar 2016

  • Technical Lead

    Jul 2010 - Aug 2012

  • QA Engineer

    Sept 2007 - Jul 2010
• 

  Cognizant

  Mar 2022 - now

  Consultant

  • Assisting with the planning and execution of projects.• Stakeholder management.• Co-ordinating with onshore and offshore Team to Conclude the deliverables.• Excellent team player with an established reputation for effectively working with diverse groups of people and adaptability to changing environments.• Participating in meetings and presenting findings or recommendations.• Experience in Crop science ,Pharma ,Quality Assurance, and CSV.• Requirement planning with Agile Practices.• Working with of Regulatory guidelines, 21 CFR 210 & 211, Part 11, GMP etc. • Independent/Support participant in Customer Audits to resolve the queries.• Preparation & Review of requirement specifications, FRS/SRS, URS, Impact Analysis, Reports, SOP, Traceability matrix IQ, OQ, PQ documentations per 21 CFR part 11 process guidelines. Show less