Basingstoke
Posted 4 weeks ago

Validation Manager

Salary: Negotiable DOE + Pension + Private Healthcare + Life Insurance + 25 days holidays + 8 bank holidays + Much more!

Location: Site based in Basingstoke

The requirements of the Validation Manager:

  • To be considered for the Validation Manager role you must have 4+ years of hands on validation experience in the IVD/Medical Devices/Molecular Diagnostics industry
  • You must also have proven people management experience (2+ years) and have directly managed laboratory scientists in a Validation Manager, Head of Validation, Validation Team Leader, Validation Supervisor, QA Validation Team Leader or closely related role
  • Preferably you be educated to a bachelor’s degree in a scientific/ technical subject such as Microbiology, Biotechnology, Immunology, Genetics, Biomedical Science or closely related
  • Knowledge of and experience with steam sterilisers 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
  • Proven ability to collaborate of multiple functions
  • Strong influencing skills and ability to multitask and prioritise work and projects
  • Able to deal with high pressure situations with a calm and logical thought process
  • Ability to work to tight deadlines and be resilient

The role of the Validation Manager:

Overview:

The Validation Manger will be responsible for developing 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.

You 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.

Key Responsibilities:

  • The Validation Manager will assume responsibility for harmonising validation processes across European sites and driving best practice
  • Responsibility 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 5 scientists currently responsible for all laboratory work associated with shelf life and stability validation
  • Provide validation reports for internal and external customers
  • To 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 my clients Microbiology 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

The Company:

  • My client is a true market leader across the life sciences sector
  • Their product range is vast and un-rivalled within the industry not only for its broad range but the true quality of the products which they offer
  • With particular focus on customer satisfaction, they retain business at an extremely high rate and have a firm majority of the market share in a variety of markets as a result

Apply today by sending your CV to Oliver Gill of Langton Howarth Ltd via email to olivergill@langtonhowarth.com or call Oliver in confidence right now for more information on 0113 243 3499 OR 07792 488 206.

You must have the right to work in the UK to be considered for this role

Langton Howarth also operates a recommend a friend referral scheme. So, if you know someone who could be good for this job, email your nominated candidate’s name and contact details in confidence via email too, and we’ll ensure you receive £100.00 of vouchers from a high street retailer of your choice once we have successfully placed the person referred by you.

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