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junior manager

4.00 to 5.00 Years   Kolkata   25 Mar, 2020
Job LocationKolkata
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaOperations Management / Process Analysis
EmploymentTypeFull-time

Job Description

  • Experience in validation of customized software.
  • CSV and QMS related SOP preparation.
  • Software verification and validation as per GxP, GAMP.
  • GXP assessment and GAMP categorization.
  • 21 CFR part 11 (ERES) and EU annex-11 assessment.
  • Analytical Instruments software Validation.
  • Preparation and Review of validation deliverable (Software & Hardware) and applicable procedures. (URS, Validation Plan, IQ, OQ, PQ scripts, Trace-ability Matrix, Test Summary Report and Validation Summary Reports).
  • Familiar with Software development Life Cycle Model
  • Review of software development document such as code review documents, Module (unit) Testing documents, Integration Testing, Penetration Testing, ERES assessment testing etc.
  • Excel sheet validation as per GAMP-5 and OECL guideline.
  • Supplier assessment as per GAMP-5 though the postal or on site auditing them for their competency for development of software.
  • Data Migration, system retirement planning and risk assessment.
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Keyskills :
codereview risk retirementplanning penetrationtesting integrationtesting qms oq gamp matrix testing sop softwaredevelopment gxp lifecycle softwaredevelopmentlifecycle cfr onsite eu erificationvalidation

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