Project Leader - Analytical
- Employer
- Thornshaw Recruitment
- Location
- Mayo (County), Connacht (IE)
- Salary
- DOE
- Start date
- 22 Sep 2020
- Closing date
- 22 Oct 2020
View more
- Discipline
- Project Management, Quality Project Management, Regulatory Project Management
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
Project Leader – Analytical
On behalf of my client, I am recruiting for a Project Leader – Analytical.
I am recruiting for an experienced Project Leader for my client’s Biologics Division located in Co. Mayo, Ireland. The successful candidate will report to the Head of Analytical Strategy and Scientific Support.
Key Responsibilities:
• Research and develop new analytical methodologies to meet client requirements and/or company strategic objectives.
• 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.
• Generate risk assessments for various projects as required.
Qualifications/Experience:
• 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.
• Experience in analytical techniques (e.g. HPLC (ELS, CAD, etc.), UPLC, GC, flame photometry, etc.) essential.
• Ability to project manage multiple studies.
• Knowledge and experience with statistical software.
• Ability to problem solve and work on own initiative.
Company
Thornshaw Scientific Recruitment was first established in 1999 and since then has become a leader in Scientific recruitment. In 2005 we partnered with Cpl Resources, one of Europe’s most successful recruitment companies.
Our wealth of experience in specialised recruitment allows us to offer the right solution to each employer, whatever their recruitment requirements.
Over the years we have developed strong relationships with our clients in the market and we pride ourselves on our repeat business from clients.
Our Industries
We are a global provider and have been providing a reputable recruitment service to the Biotech, Pharmaceutical, Clinical Research, Medical Device, Engineering and Healthcare industries for over 20 years.
Our Specialities
Clinical Research, Regulatory Affairs, Quality Assurance, Medical Affairs, Pharmacovigilance, Biostatistics, QC, Validation.
Our Mission
For further details on our services contact Tina at +353 1 2784701 or email tdunne@thornshaw.com
- Website
- http://www.thornshaw.com/
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