Validation Specialist

Recruiter
Optimus Search Limited
Location
Wrexham (Wrecsam)
Posted
24 Jan 2018
Closes
18 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Are you a Validation Specialist interested in working for one of the UKs leading names in High-Tech Pharmaceutical Engineering? Are you looking for something new?! Then stop what you are doing and read on!Title: Validation SpecialistRate: NegotiableLocation: North WalesPositions Available: 1Type: Contract (6 Months)A Fantastic new role has just opened up at one of our leading UK based clients offering the successful candidate the opportunity to join a hard-working team working on exciting projects in the pharmaceutical sector.The proposed start date is ASAP- We need YOUResponsibilities include: * To define and implement the qualification strategy to establish and maintain the validated status of facilities, utilities, equipment and processes. To lead the validation activities associated with specific projects. * Ensure the validated status of site facilities, utilities, equipment and processes is established and maintained in accordance with internal procedures, regulatory requirements and industry guidance / standards * Define and execute the validation strategy associated with site projects covering a range of a range of facilities, utilities, equipment and processes in accordance with project timelines and customer expectations. * Define the validation testing strategy for requalification / revalidation activities. Execute requalification, revalidation and periodic review activities in accordance with the Validation Master Plan schedule. * Maintain an awareness of regulatory and industry best practice trends, hot topics and changes in relation to validation. This includes changes to corporate quality guidance and standards * Identification and implementation of continuous improvement initiatives to ensure lean ways of working. Regularly leads departmental continuous improvement projects to ensure a lean validation lifecycle. * Drive a risk based validation lifecycle utilising quality risk management principles and tools (e.g. FMEA, HAZOP) to ensure that risks are appropriately identified and documented * Provide expertise for the investigation and compliant resolution of non-conformances encountered during (re)qualification / (re)validation activities and site Unplanned Events * Present validation packages during regulatory / internal / customer audits. . Participate in the response to regulatory audit observations (as required). * Review proposed Change Controls (low to mid complex changes) to assess the impact on the validated status and determine the validation strategy as required. * Liaise with vendors to ensure the correct standards are delivered to facilitate an integrated approach to commissioning and qualification. * Provide co-ordination and leadership of individual contract resource (as required). Regularly provide oversight of contract / vendor resource on an individual project basis to ensure validation activities are delivered in compliance with site procedures and in accordance with the project schedule. * Generation, peer review and approval of technical documentation and Generate and maintenance of Validation Plans and Validation Master Plans. * Provision of data to support departmental Key Performance Indicators (as required). * Support the training and development of junior members of the Validation n team to enhance the level of experience and expertise.Requirements * Good understanding of the regulatory requirements and current industry standards / best practices pertaining to validation. * Subject Matter Expert with an excellent technical, compliance and practical understanding of specific aspects of validation as defined by the Validation Manager. * A natural tendency to continuous improvement. Basic / good understanding of the foundation principles of Lean Six Sigma. * Excellent technical documentation generation and review skills ensuring the content is technically sound, adheres to applicable site procedures and is suitable for supporting regulatory submission. * Organised, target orientated, customer focussed, clear communicator, ability to deal with people at all levels, lateral thinker, good negotiator, ability to prioritise, ability to balance objectives. * Able to work effectively as a part of a cross-functional team and maintain good relationships with internal and external stakeholders.If you are interested please do not hesitate to email or call me!Shubert@optimussearch.com+44 20 30969 392

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