Computer System Validation Engineer

Optimus Search Limited
United Kingdom
40 - 70 p hour
27 Sep 2017
03 Nov 2017
Contract Type
Full Time
Are you looking for a new position? Are you ready to take a step in the right direction? Then stop, read and APPLY! An award-winning biometrics Pharmaceutical company are looking for a great, hard-working Quality Assurance Auditor! Are you the candidate they are looking for? Title: Computer System Validation Engineer Rate /hr: Negotiable Location: Galway/Cork Contract Position (Rolling) A Fantastic new role for a great company based in Ireland are now urgently recruiting for CSV engineers and with the start date being ASAP we need YOU! Responsibilities include: * A CSV consultant will use his/her knowledge of FDA cGMP and related regulations and guidelines, and specific knowledge of computer validation methodologies and principles to perform CSV on a variety of systems and programs. * Leading and executing CSV activities on site * Running CSV life-cycle activities in conjunction with relevant stakeholders on time * Coordinating CSV activities and acting as the central point of contact for the site CSV to deliver projects on schedule * Audit computerized systems at the site and monitor the implementation of corrective and preventive action plans. * Familiarity with cGMPs, GAMP, ICH Q7A and basic validation practices (IQ/OQ/PQ) * Experience of QA in a FDA regulated environment is preferred. * Past experience writing, reviewing and executing computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, summary report). * Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements. * Technical writing experience * Generation of Validation documents. * Review and Approval of Validation documents. * Possesses a thorough understanding and experience of Validation Principles with good knowledge of GAMP 5, ICH Q7A, FDA parts 210 and 211. Basic requirements: * Strong Project Management experience (preferred but not required) * Documentation management * Excellent communication skills. * Team player * Proficiency with MS Office tools. * An Honors bachelor's degree in a Scientific, engineering or Computer science field * 2 years or more experience in CSV
This job was originally posted as