Computer System Validation Engineer - Lab Systems

Job type:
on-site
Start:
n.a
Duration:
n.a
From:
Quanta Consultancy Services
Place:
India
Date:
05/31/2016
Country:
flag_no United Kingdom
project ID:
1139203

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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 on