Computer System Validation Engineer - Lab Systems

Job type:
Start date:
8-18 months
Quanta Consultancy Services
Published at:
flag_no India
Project ID:

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Pharmaceutical manufacturing plant in India have a long term urgent contract requirement for an experienced CSV Engineer with Lab Instruments and software experience to work on a large scale remediation programme. This is to get the site moving towards manufacturing, GMP and FDA readiness.
Experience required
  • Experience in Computer Systems Validation in an FDA regulated environment is preferred
  • Experience in Infrastructure Qualification
  • Knowledge of 21 CFR Part 11
  • Knowledge and experience working with GAMP5 guidelines for computer systems validation
  • Past experience in writing, reviewing and executing computer validation documentation (Validation Plan, IQ, OQ,PQ, Risk Assessments, Requirement Specifications, RTM, Summary Reports)
  • Experience in validating one or more of the following types of systems is desirable: Chromeleon Chromatography Data Systems, UV Probe, TOC, Analytical Lab Instrument Software
  • Bachelor's degree preferred in Computer Science/IT, Engineering or related discipline and 5+ years' experience in a computer systems validation role
  • Excellent communication skills
  • Proficiency with MS Office Tools
  • Documentation Management
  • Strong Project Management experience, preferred but not required
  • CSV Lab Instruments ill include:Lab X, RFM, Millitrack, HMI, UV Probe, Chromeleon. Good Laboratory systems will be essential!
Flights, accommodation, per dieme, food included together with the hourly rate. For further information on this project call me