QC External Support Specialist

2 weeks ago

Dublin, Dublin City, Ireland Cpl Healthcare Full time
Cpl in partnership with our client are seeking a QC External Supply Specialist to join the 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.
- 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.

About You

To be successful in this role you will require:

- 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.
- Working knowledge of six sigma, Lean Tools/management systems, QTS, eQMS and GDMS.

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