Description
I am currently recruiting for a CSV Consultant for a 6 month contract for a Pharmaceutical company based in the South - West.Scope includes, but is not limited to:-
Computer System Validation of Production and Engineering Equipment * Generation and execution of validation protocols (IQ/OQ/PQ) and associated summary reports, in accordance with current protocols and procedures.
* Generation, review and approval of Risk Assessments in accordance with current protocols and procedures
* Liaise with user departments (Production, Engineering, QA, Validation, IT, Vendors and Senior Management) where required
* Provide progress reports to CSV Manager Specific Current Projects
* Witness Site Acceptance Test for SCADA System.
* Report Site Acceptance Test for SCADA System
* Write CSV PQ Protocol for AKTA Chromatography SKID
* Perform CSV PQ of Chromatography SKID.
* Report CSV PQ of Chromatography SKID.
* Write CSV PQ Protocol for Ultra Filtration SKID
* Perform CSV PQ of Ultra Filtration SKID.
* Report CSV PQ of Ultra Filtration SKID.
* Generate reports on configuration changes made to systems e.g. Eurotherm Data Monitoring Systems.
* Generation of summary reports documenting low level changes that have been made to systems computerised systems.
* Generation of periodic review reports of computerised systems.
The idea candidate will need strong knowledge of the following:
GAMP4/5 life-cycle
FDA 21 CFR Part 11
EudraLex - Volume 4 Good manufacturing practise (GMP)
Guidelines "Annex 11 (Computerised Systems)"
* Extensive knowledge of, and experience in, GMP Equipment qualification
* Extensive knowledge of Full-Life cycle GMP CSV Validation
* Sound knowledge and experience of 'Risk-Based' approach to validation This is an excellent opportunity for an immediate start and competitive hourly rates.
If you are interested in this opportunity please contact Reshma Patel on or email immediately