Your role will be in the Quality Control Department as part of an expanding and diverse team of welcoming and supportive colleagues. You will be directly involved in providing quality and analytical expertise to external customers and you will also provide support to regulatory submissions in those markets.
This is an exciting opportunity to join a world class facility, which is dedicated to bringing therapies to the market that will significantly improve patients’ lives.
Support external analytical method transfer projects for both established and upcoming new products. You will coordinate and execute activities to ensure completion of method transfer projects to schedule.
Support regulatory activities including those related to review of analytical sections in both new and updated submissions as well as query responses. Support ancillary activities to enable local market testing as part of dossier pre-approval requirements.
About the Role
- Technical review and critique of analytical sections/regulatory documents for all new filing applications for established and new 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.
- Provide technical support to all new country launches.
- Technical/analytical support to Board of Health Labs on analytical queries related to products.
- Management of external analytical method transfer projects to rest of world markets and new emerging markets/localisation projects.
- Liaise with customers both internal and external to support overall method transfer processes.
- Support importation testing queries and support for rest of world labs via country affiliates and from packing sites.
- 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.
- Support operations of the 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 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 Manager/Supervisor.
- Some travel may also be required as part of this role.
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 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 and Lean Tools/management systems.
- Demonstrate Company Values and Behaviors.
- Adhere to all HR Policies as appropriate.
- Recognition is actively practiced by you and across the team.
- Proactive engagement with key stakeholders.
- Best practices developed and shared with other teams /sites.
- Best practices actively sought and copied.
- Proactive & effective communication within and across teams.
- Support use of Lean tools within the team to manage workload and implement continuous improvements.
In order to be considered for this position you need to be legally eligible to work in Ireland.
The company is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.