Project Leader | Mayo
- Leading Pharma Company in the West of Ireland
- Excellent career progression opportunities along with a generous package
- Oradeo Recruitment is presently seeking interest for a Project Leader to join our clients in Mayo.
The main duties & responsibilities shall be:
- Oversee and lead the establishment/transfer of multiple methods from client to our test labs across a number of different disciplines.
- Ensure all new methods are validated in accordance with ICH guidelines, where appropriate.
- Draw up study plans and execute studies in strict accordance with study plan and SOPs ensuring full GMP regulatory compliance, where appropriate.
- Liaise with the Quality Department for the generation of audit responses, deviation reports and for the compilation of study reports.
- Responsible for leading laboratory investigations, where necessary.
- 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.
- 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, where required.
- Generate risk assessments for drug products, substances and processes as required.
The following are minimum requirements related to the Project Leader position.
- PhD in a relevant science discipline (e.g. Chemistry, Biochemistry or Biotechnology)
- A minimum of 3 years relevant experience in Scientific Research preferably within a GMP regulated environment (EMEA/FDA) within the Pharmaceutical, Medical Device, CRO Industry.
- Experience in study design, assay development, optimization, ICH analytical validation and project management essential.
- Experience in analytical techniques, Molecular biology techniques e.g. PCR and Q-PCR or Cell Culture Techniques and Virology desirable.
- Ability to project manage multiple studies.
- Knowledge and experience with statistical software.
- Ability to problem solve and work on own initiative.
For more information about this Project Leader position or other opportunities, contact Angela Haran at Oradeo Recruitment confidentially on +353 1 687 7188 or apply in confidence.
About Oradeo - Oradeo Recruitment are specialists in the life sciences, pharmaceutical, construction & engineering sector. We are a leading service provider in Ireland, UK and Europe for professional recruitment services and the provision of managed labour in Construction & Civil Engineering, Data centres, Mechanical & Electrical, Life Sciences and Renewable Energies sectors