|Job Ref:||204786599||Employer:||cv-library.co.uk||Industry:||Civil and Structural||Job Type:||Contract||Country:||United Kingdom||County/State:||Berkshire||City:||Slough||Address:||Post Date:||14/10/2016 03:35|
PM Group is an international engineering, architecture and project management firm. We collaborate with many leading private companies and major public sector organisations, and are currently involved with 30 major projects throughout Europe, Asia, USA and the Middle East. Established in 1973, PM Group now employs over 2,100 people, based in 25 locations worldwide. Our areas of specialty are in the Pharmaceutical, Bio-pharmaceutical, Food & Beverage, Advanced Manufacturing, Healthcare, Education, and Energy sectors|
Working with one of our Clients in Slough, UK. The engineer will be responsible for developing a process for and performing of validation of computer and/or automation systems compliance current Good Manufacturing Practices (cGMPs) and all other regulatory and/or guidance requirements such as Annex 11, GAMP and 21 CFR Part 11.
The Engineer will validate computer and automation systems ensuring compliance to required regulatory requirements.
Give guidance on all activities related to computer and automation systems validation.
Support activities include, but are not limited to, SOP creation, documentation review and approval. Including change controls, assessment plans, risk assessment reports, compliance plans, user requirements, system and user acceptance testing protocols, traceability matrix, error reports/defect report forms and summary reports.
Compiles and analyses validation data and makes recommendations for changes and/or improvements.
Investigate and trouble-shoot problems which occur and determine solutions.
Maintain all documentation pertaining to computer systems validation. Participates on cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups. Contributes directly to the completion of projects through the management of assigned contract personnel, development and execution of validation change control documents, and development and review of protocols, reports and data tables generated by peers and contract personnel.
As required, prepares summaries of validation testing for regulatory submissions and presents validations to regulatory agencies.
Coordinates assigned projects and represents department on project teams.
Serves as an information resource for computer systems validation to validation engineers, contractors and vendors.
Resolves computer systems validation issues of moderate scope with limited direct supervision.
You will be degree qualified in a relevant Engineering subject or equivalent and have a proven track record of working within the Pharmaceutical or Life Sciences industry