Babi********

Computer System Validation

  • 500049 Hyderabad India 
  • Graduation: M.Pharm, PGDCA

  • Hourly / Daily / Monthly Rates: 700 / hour 2500 / daily 30000 / monthly

  • Languages: English(Native or Bilingual) | Hindi(Native or Bilingual)

  • Last Update: 03.06.2020 at 10:48

Job Type
Part Time
Availability
Not Available
Place
Hyderabad
Country
India

Skills

  • Create, review and/or approve Good Manufacturing Practice (GMP) documentation such as standard Operation Procedures (SOP’s), Quality Risk Assessment, Impact Assessment, Vendor Assessment, GxP Assessment, Validation plans, User Requirements Specification (URS), Functional and Design Specifications (FS and DS), testing protocols (IQ/OQ/PQ), User Acceptance Testing (UAT), Traceability Matrix (TM), Validation Reports and Change Control documentation to support all validation activities per the Validation Master Plan
  • Performed all aspects of CSV including planning and developing validation strategies in conjunction with the customer and system owners creating all required GMP documents, and the actual validation(s) in unification with system owners per the Validation Master Plan (VMP)
  • Single point contact of all CSV activities for GxP Global Computerized Systems and act as an interface between IT and Business for eCompliance topics in relation to GxP classified Computer systems promoting a Quality culture
  • Review and approve project related documents for Global GxP relevant systems including determination of GxP applicability for all Global GxP and non GxP relevant systems
  • Preparation, Quality review and designing documentation (URS, FS, DS), Validation (IQ, OQ, PQ, TM), Quality systems (Change Control, CAPA, Non-Conformance and Re-qualification), Data Restoration, Data Backup. Good Knowledge of handling and execution of TrackWise, LIMS, SAP, Miracle and DocHub
  • Vendor Co-ordination for trouble shooting and fixing issues and requests that arise related to Hardware, Application during implementation, migration and major upgrades
  • Ensure life cycle activities of global GxP systems are planned and appropriately supported for Periodic re-evaluation of validation status, Change Controls and Incidents. Collaborated with Quality Audit for on-going review of audits related to CSV and ensure gaps are identified and adequately addressed
  • Knowledge of CSV principles and regulatory guideline for Computerized and Automated Applications like 21 CFR Part 11, GAMP 5, ICH Q9/10, EU Annexure 11. Validation of Application through V-Model and SDLC model. As a lead attended project meetings, have good communication, technical writing skills and have driven progress throughout project life cycle


Refrences

Projects handled- Russia Serialization, Domestic Serialization, EU FMD serialization, Line system Application, Retrospective review 


Time and Spatial Flexiblity

Distance part time 

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