- Leading Pharma Company in the West of Ireland
- Excellent career progression opportunities along with a generous package.
For our Client in Ireland we are presently seeking interest for Project Leader Bio Safety to join our clients in Mayo. This role shall report to the Biosafety and Bioassay Development Manager and the main duties & responsibilities shall be:
- Draw up study plans and implement studies in strict accordance with plan ensuring full GMP regulatory compliance.
- Liaise with the Quality Department for the generation of audit responses, facility replies, deviation reports and for the compilation of study reports.
- Responsible for leading laboratory investigations.
- Responsible for reporting project progress information to Management.
- Provide technical training to scientific team as required.
- Day to day liaison with clients regarding current and new projects.
- Involvement with regulatory and client audits.
- Research and develop new methodologies to meet client requirements and/or company strategic objectives.
- Responsible for generation of quotations for new studies and client enquiries.
- Manage and provide weekly and monthly sales figures for specific studies.
- Ensure all new methods are validated in accordance with ICH guidelines
- Ensure all new equipment is qualified and validated in accordance with GMP and corporate validation requirement standards and guidelines.
- Generate new and update current standard operating procedures.
- Generate risk assessments for various projects as required.
- Act as Project Manager for in-vivo rodent studies.
- MSc. or PhD in a relevant science discipline (e.g. Biomedical Science)
- A proven track record and experience of working in a GMP regulated environment (EMEA/FDA) within the Pharmaceutical/Medical Device/CRO Industry.
- Experience in study design, assay development, ICH analytical validation and project management.
- HPRA project license authorisation desirable but not essential
- Experience in in-vivo Bioassays and model development.
- Experience in immunology, immunogenicity, toxicity and safety studies. (analytical techniques also would be an advantage).
- Ability to manage multiple studies
- Knowledge and experience with statistical software.
- Ability to problem solve and work on own initiative.
To apply for the above offer send your CV to email@example.com and put “Project Leader Bio Safety / Mayo” in email’s title.