Description
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