Analytical Support Specialist

5 days ago


Dublin, Dublin City, Ireland CPL Full time

About CPL in Partnership with our Client

We are seeking a highly skilled Analytical Support Specialist to join our team at our state-of-the-art site in Dublin, Grange Castle for an 11-month fixed-term contract with hybrid working.

About the Role / Job Responsibilities

  • Manage external analytical method transfer and new product introduction projects, including mRNA products to rest of world markets and new emerging markets/localisation projects.
  • Liaise with customers both internal and external to support overall method transfer processes.
  • Provide technical support to all new country launches.
  • Author, review, and critique of analytical/regulatory leaflets for all new filing applications for established and new products, including mRNA products.
  • Address product analytical queries from global regulatory teams in support of new and updated submissions.
  • Coordinate and technically review responses to agency questions on analytical methods.
  • Support importation testing queries and support for rest of world labs via country affiliates and from packing sites.
  • Support the implementation of analytical methods in Official Medicines Control Laboratories (OMCL) and National Control Laboratories (NCL) as part of product market release.
  • Technical/analytical support to Board of Health Labs and OMCL/NCL laboratories on analytical queries related to products.
  • Representative/active participant on cross-functional analytical and product teams.
  • Representative at Change Control review boards to assess impact of all changes presented and follow up on assigned implementation activities.
  • Initiate Change Controls and author, review, and approve technical documents, including product specifications, Standard Operation Procedures (SOPs), and any other technical document as required.
  • Support operations of the Quality Control testing laboratories as requested by QC management, for example, assay execution or data review.
  • Support teams to provide QC assessments/information related to analytical test procedures/data trends/other analytical data as required.
  • Support opportunities for Continuous Improvement within the team and embrace the company's culture to own and drive any activities associated with delivering these improvements.
  • Provide support to agency site inspections as required.
  • Host visits to site from Board of Health Laboratories or other government agencies from ROW in support of future import testing requirements locally or as part of new product submissions.
  • Implement and adhere to appropriate levels of cGMP within the team and promote safety awareness and the established culture of incident- and injury-free within the area.
  • Perform and assist in additional duties as may be directed by QC External Support Manager/Senior Manager.
  • Some travel may also be required as part of this role.


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