Validation Manager

Recruiter
THERMOFISHER
Location
Cliddesden, UK
Salary
Competitive
Posted
27 Jul 2019
Closes
02 Aug 2019
Ref
1182368279
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Job ID : 96926BRLocation : United Kingdom - Basingstoke : Job DescriptionValidation Manager - Basingstoke, HampshireMicrobiology DivisionThe Job:To provide validation leadership to MBD European manufacturing sites developing, harmonizing and implementing best practice policies and protocols. Managing the stability testing program, based at Basingstoke, ensuring all finished product and raw materials are tested and reported in accordance with regulatory requirements and to the agreed schedule.The job holder will deliver validation related projects and in addition be responsible for developing and managing the Product Stability Team. The position holder will report into the European Quality Director. The role has both budgetary and line management responsibilities.What will you do?Responsible for harmonizing validation processes across European sites and driving best practice.Responsible for ensuring manufacturing sites have up to date Site Validation Master Plans.Create and, when required, execute validation test protocols and document test results in accordance with SOPs.Communicate and provide information by relevant methods, internally and externally to ensure effective functioning of business processes.Respond to and effectively resolve customer enquiries.Adhere to stated policies and procedures relating to H&S and Quality Management.To manage the product stability testing program for specified products, intermediates, third party products, new and redeveloped products.To manage the laboratory team of scientists responsible for all laboratory work associated with shelf life and stability validation.Provide validation reports for internal and external customersTo manage product evaluation projects.To plan and manage the team in line with agreed budgets and goals.To manage and develop the stability program for Oxoid products, reporting project information and progress to the Quality Manager.To prepare Compliance SOPs and product testing protocols in accordance with customer requirements (internal and external) regulatory guidelines and company requirements.To act as main contact for product specific validation enquiries for the business.To prepare validation plan with stakeholders, Prepared Media Sites and ensure that they are informed of progress.To provide validation expertise to product risk assessment process.Who we are looking for: experience, skills & abilitiesPreferably educated to a Bachelor's degree in a scientific/ technical subject.Solid validation experience in an IVD/MD industry.Knowledge of and experience with steam sterilsers would be an advantage.Willingness to travel within U.K and abroad.Knowledge of regulatory requirements e.g. ISO 13485, 9001, 17025 and the IVD Directive.Non-Negotiable Criteria: Extensive Validation experience in an IVD/MD industry.Proven managerial experience.Proven ability to collaborate of multiple functionsWhat's in it for you?Excellent progression opportunities with a large and growing global employer;Competitive salary;35 hour working week with an early Friday finish;25 days annual leave;Private healthcare cover;Employee assistance programme;Range of flexible benefits including cycle to work scheme, travel insurance, gymflex amongst others;About us:As the world leader in serving science, our work is more than something that fills our days. When you're part of Thermo Fisher Scientific, you'll do challenging work, and be part of a team that values performance, quality and innovation. With revenues of $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.Each one of our 70,000 extraordinary minds has a unique story to tell. It's not just a career, it's a chance to realise your best - professionally and personally.Join us and contribute to our mission-enabling our customers to make the world healthier, cleaner and safer. Apply today! - Job reference: 96926BR*LI-KP1

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