QC External Support Specialist

Cpl in partnership with our client Pfizer are seeking a QC External Supply Specialist to join the team at their state of the art site in Dublin, Grange Castle for a 12 month contract with hybrid working model.

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• Management of 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.
  
• Technical 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.
  
• Co-ordination and technical review of 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 (SOP’s) 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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• B.Sc. degree in biological/chemical sciences, business, or other related technical degree or equivalent experience in regulated industry.
  
• Minimum of 4-6 years working experience within a QA/QC GMP environment in a pharma/ biotech company.
  
• Experience with technical elements of the analytical method validation and transfer process.
  
• Proven knowledge in analytical techniques, analytical instrumentation theory and practice.
  
• Proven ability to recognise problems with equipment, methods, software, procedures and resolve the issues.
  
• Experience working with regulatory submission processes and regulatory queries.
  
• Experience with Quality and Laboratory systems an advantage.
  
• Excellent communication, and interpersonal skills.
  
• Proven success in proactive project management.
  
• Experience in managing multiple projects to tight timelines and reporting regularly to management within the organisation.
  
• Proven ability to communicate problems and required resolution in a positive and proactive manner.
  
• Self-directed, self-motivated with a demonstrated record in project accountability.
  
• Demonstrated success in networking across sites/functional teams.
  
• Ability to work independently, as well as a member of a team in a dynamic, fast-paced environment. xcfaprz
  
• Working knowledge of Six Sigma, Lean Tools/management systems, QTS, eQMS and GDMS.