Job Description
Cpl, in partnership with our client, are seeking a QC External Supply Specialist to join their team at their state-of-the-art site in Dublin, Grange Castle, for an 11-month fixed-term contract with hybrid working.
About the Role/Job Responsibilities
* 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.
* Coordination 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.
About You
* To be successful in this role, you will require:
* A B.Sc. degree in biological/chemical sciences, business, or other related technical degree or equivalent experience in regulated industry.
* A 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.
* Working knowledge of six sigma, Lean Tools/management systems, QTS, eQMS, and GDMS.