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Validation Specialist

Permanent  for Search Consultancy in Winsford

Validation SpecialistWinsfordMy client, a leading Medical Device company based in Winsford are looking to recruit for a Validation Specialist to join their quality team. Reporting into the Quality Manager, you will manage all validation projects within the business in compliance with applicable regulatory agency standards. Primary duties will include writing and executing validation protocols for facilities, equipment and processes, ensuring they are undertaken according to FDA, EU and company standards.Key Accountabilities:* Developing validation project plans and timelines.* To write and execute validation protocols, such as installation, operational and performance qualifications (IQ, OQ, PQ’s), Factory acceptance tests (FAT), site acceptance tests (SAT), Process optimisation, Process validations (MV’s) and Cleaning Validations (CV’s)* Work within cross functional teams to manage projects.* Ensuring work is completed in compliance with applicable BSI, FDA and all other regulatory agency standards.* Undertake activities related to NC, CAPA and risk management, as required.* Follow and adhere with all company policies and procedures to maintain a safe working environment.The ideal candidate will have:* Degree in a Science / Engineering related field or equivalent.* Validation experience within a regulated manufacturing environment.* Understanding of Medical Device Regulations including ISO13485 and FDA QSR.* Ability to interpret and apply legislation and policy.* Strong analytical and problem solving skills.* Effective written and verbal communication skills.* Ability to work well within a team with a flexible approach and on own initiative.* Knowledge of Health and Safety in the workplace.* Experience of Lean Manufacturing, Six Sigma and continuous improvement practices.* Previous Quality Engineering experience would be beneficial.For more information on this role please contact Alannah Fisher on 0161 835 8640 or alternatively email your CV to

Job added on 10-10-2014