Kelly Services are seeking an experienced Project Leader for our Global Pharmaceutical client in Co. Mayo.
Duties and Responsibilities:
- 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.
- 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.
Please apply through the link or contact Niall Curley on 086-4113572 for more information.
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.