Cpl, in partnership with our client, are seeking a QC External Supply Specialist to support the team at their state-of-the-art site in Dublin, Grange Castle.
About the Role/Job Responsibilities:
* Management of external analytical method transfer and new product introduction projects, including mRNA products, for global markets and localization initiatives.
* Liaise with customers, both internal and external, to support overall method transfer processes.
* Provide technical support for all new country launches.
* Author, review, and critique analytical/regulatory leaflets for new filing applications, including mRNA products.
* Address product analytical queries from global regulatory teams in support of new and updated submissions.
* Coordinate and review responses to agency questions on analytical methods.
* Support importation testing queries and rest of world labs via country affiliates and packing sites.
* Support the implementation of analytical methods in Official Medicines Control Laboratories (OMCL) and National Control Laboratories (NCL) for product market release.
* Provide technical/analytical support to Board of Health Labs and OMCL/NCL laboratories on analytical queries related to products.
* Representative/participant on cross-functional analytical and product teams.
* Representative at Change Control review boards to assess change impact 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 other technical documents as required.
* Support operations of Quality Control testing laboratories as requested by QC management.
* 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 promote the company's culture to drive improvements.
* Provide support to agency site inspections as required.
* Host visits to site from Board of Health Laboratories or other government agencies for ROW in support of future import testing requirements locally or as part of new product submissions.
* Implement and adhere to appropriate cGMP levels within the team and promote safety awareness and incident-free culture.
* Perform and assist in additional duties as directed by QC External Support Manager/Senior Manager.
* Some travel may be required for this role.
About You:
To be successful in this role, you will require:
* B.Sc. degree in biological/chemical sciences, business, or other related technical fields, or equivalent experience in regulated industries.
* Minimum 4-6 years working experience in a QA/QC GMP environment in a pharma/biotech company.
* Experience with technical elements of analytical method validation and transfer processes.
* Proven knowledge in analytical techniques, instrumentation theory, and practice.
* Ability to recognize problems with equipment, methods, software, procedures, and resolve issues.
* Experience working with regulatory submission processes and regulatory queries.
* Experience with Quality and Laboratory systems is an advantage.
* Excellent communication and interpersonal skills.
* Proven success in proactive project management.
* Experience managing multiple projects to tight timelines and regular reporting to management.
* Ability to communicate problems and required resolutions 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 and 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.