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Validation Engineer - Pharmaceuticals, GAMP job in Warrington

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Job Ref:  429102125
Employer:  Adzuna
Job Type:  Permanent
Country:  United Kingdom
County/State:  Cheshire
City:  Warrington
Post Code:  MK46
23/09/2016 02:54
Validation Engineer - Process/Computer Systems Validation - Cheshire Job Purpose To perform validation activities in accordance with the Validation Master Plan (VMP) and associated validation matrix ensuring that all validation is performed in compliance to GxP with a key emphasise on providing expertise in all aspects of computer system validation. Main Accountabilities Execution of all validation related activities, including computer software validation, process validation, facilities and equipment validation. Author and review validation and technical documentation. Act as a QA change owner for GxP systems, including risk identification and mitigation, responsible for tracking changes through to completion. Recommend and manage corrective and preventive actions (CAPAs) to improve compliance. Provide technical support to production to maintain GMP and production efficiency. Complete risk assessments and documentation as required to ensure that the production equipment and production facilities comply with GMP and the relevant HSE guidelines. Maintain compliance with Data Integrity Regulations, GAMP standards, 21 CFR Part 11 and applicable regulatory guidelines. Produce / review and maintain Standard Operating Procedures. Prepare and complete product quality reviews to ensure compliance with regulatory requirements and to identify areas for improvement. Assist in the resolution of day to day technical issues with respect to processes and equipment. Ensure compliance with all recognised and relevant standards, internally and externally, to ensure patient safety and in order to comply with legislation as defined by government and statutory bodies. Experience & Qualifications A degree or equivalent in a scientific or technical discipline. Strong validation background, particularly in computerised systems validation (including GAMP5 principles and Electronic Records and Electronic Signatures regulations). Experience in the validation of small instruments/systems (balances, pumps, isolators etc). Experience in thermal mapping of fridges/freezers/incubators desirable. Clean room experience to at least grade C desirable. Knowledge of microbiology desirable. Experience of facilities validation (HVAC, NVP testing etc) desirable but not essential. Please apply now to be reviewed immediately This job was originally posted as NA
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