This global pharmaceutical leader focuses on improving patient's lives by identifying, developing, and commercialising meaningful products that address unmet medical needs. Since their founding, they have focused on putting the patient first and this remains their priority as they continue to develop, acquire, and commercialise new treatment options for patients with challenging conditions that no one else is tackling. Currently employing over 40,000 staff globally with offices in the U.S. and Europe, they are a continually growing company with a broad portfolio and a very healthy pipeline. This organisation has an incredible manufacturing footprint here in Ireland and one of their plants is currently in need of a Senior Microbiology Laboratory Manager to join their operation.
Key responsibilities would include:
- Manage and control the microbial testing of pharmaceutical products for release.
- Ensure highest quality standards are maintained in areas of responsibility and that industry best practice is adopted in accordance with current GLP, GMP and regulatory body directives.
- Ensure all laboratory analysis is carried out in a safe, efficient, and timely manner and ensure that systems and methods of analysis, sampling and testing are in place to allow for the generation of valid data.
- Ensure validity of all test methods in the laboratory are established and documented.
- Interact efficiently with other department managers/ directors.
- Ensure department readiness for audits both internal and external authorities. Represent Quality management for microbiology and interface with investigators during these inspections.
- Support continuous improvement projects such as 6S and lean processes for the laboratory.
- Provide input to regulatory files in support of new product submissions and approvals.
- Min Level 8 degree in science-related discipline (preferably Microbiology / Pharmaceutical Sciences).
- 5-10 years' experience in pharmaceutical industry in supervisory/managerial role (ideally within a microbiology department).
- Knowledge of working within an FDA/IMB regulated facility (preferably sterile injectables) / aseptic processing.
To discover more about this opportunity, apply now or contact Déanna Healy at HRM on +353 87 636 9263 for a confidential discussion.