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Product Stewardship Specialist

The BBI Group
Job LocationNewport, Gwent
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

The CompanyBBI Solutions has served the global diagnostics industry for over 50 years, as a leading developer and manufacturer of raw materials and finished test platforms for the in-vitro diagnostics market. Product ranges include antigens, antibodies, enzymes, serums and plasma’s as well as renowned labels for lateral flow and ELISA assays.Our mission is to deliver exceptional products and technologies that people rely on to enjoy a better quality of life. Through innovation, partnership, effective delivery and the collaboration of our people, we constantly strive to help set industry standards, engender trust and build our reputation for excellence.We currently have an exciting opportunity for a Product Stewardship Specialist to join us on a permanent basis at our Crumlin site.BenefitsThe salary offered for this role is competitive and makes up part of BBI’s attractive benefits package, which includes:

  • 5% contributory pension scheme
  • Life Assurance
  • Private health care scheme
  • Generous annual leave package totalling 32 days (inclusive of bank holidays)
  • Cycle to work scheme
    • The RoleAs a Product Stewardship Specialist, you will be responsible for providing support for the BBI product portfolio, with respect to all applicable regulations (IVDR, MDR, Falsified medicine directive, API regulations, Pharmacopeia’s etc) as well as software implementation and process improvements. You will work within the Quality Assurance and Regulatory Affairs department to ensure the sustainability of all BBI products.Key responsibilities will include but not be limited to;
  • Prepare and submit compliance reports and other documentation
  • Interact with other functions to provide product stewardship support during new product development and management of change activities
  • Develop processes including documentation (software processes, standard operating procedures and database implementation)
  • Maintain thorough understanding of product stewardship regulations, especially EU legislation and their application in the diagnostics and Pharma industries
  • Maintain familiarity with global regulations in all territories where BBI products are marketed ahead of regulatory changes
  • Lead and project manage QARA/Product stewardship improvement projects
  • Act as SME and provide guidance to other departments with regard to product stewardship during the product lifecycle
  • Generation of and training other departments/new members of staff as and when required for QMS and or regulatory requirements
  • Maintain oversight of all BBI marketing material and ensure robust review and approval processes are in place
  • Maintain all regulatory registrations for BBI manufacturing sites (FDA, PMDA, SAHPRA etc.)
  • Assist with the maintenance of any technical files
  • Assist with continuous process improvements
    • RequirementsThis role will be best suited to someone who has a science degree and relevant industry experience. Experience with diagnostics and pharma regulations would also be a distinct advantage, especially ISO 13485.BBI is a fast-paced organisation and so you will need to demonstrate that you have a strong attention to detail and excellent organisational skills. A strong team working ethic and a drive for results are also important.If you are an internal employee applying for this vacancy you and your manager are required to complete an internal transfer form. This needs to be completed in full and attached to your application along with your CV and cover letter.

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