Analytical Support Specialist
5 days ago
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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