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Details

Projects Development Analyst


Reference:ARKL-212835 Location: Dublin
Qualification:MastersExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Analytical Chemist, Biochemist

JOB PURPOSE
Our clinent is a large pharmaceutical company based in Dublin. They wish to recruit an Analyst to join their Technical Services team. The successful candidate will be responsible for development and validation of new methods, troubleshooting instruments and methods, and writing protocols and reports within the required timelines and in compliance with Regulatory, cGMP and GLP guidelines.

KEY TASKS AND RESPONSIBILITIES

• Support new product introductions, working with internal and external teams to develop and transfer analytical methodologies. This includes method development, optimization and/or validation.
• Providing technical guidance on analytical method development and optimisation.
• Responsible for investigation and technical support to QC.
• Train development lab and QC staff so they can successfully implement methods.
• Support and troubleshoot methods throughout their first application.
• Versatility to assist with training, metrology, sample management and report writing functions.
• Design, execute, and analyse experiments.
• Participating in project and cross departmental meetings.
• Reviewing documentation for new product introduction (NPI), product development and validation to ensure they meet the standards for regulatory approval (HPRA).

SKILLS, EXPERIENCE AND QUALIFICATIONS

• A master degree or Ph.D. in analytical science or another related science discipline – Pharmaceutical analysis is desirable
• Minimum of 5 years’ work experience in a pharmaceutical R & D and cGMP environment with extensive experience of analytical testing demonstrating excellent knowledge of analytical testing techniques
• Strong background in method development and validation for HPLC, GC and UPLC.
• Proficient in operation and troubleshooting of a wide variety of analytical instrumentation.
• Full understanding of cGMP requirements, ICH guidelines, Ph. Eur requirements along with EMEA guidance.
• Effective technical writing skills
• Excellent interpersonal, leadership, communication (written and verbal) and time-management skills are essential.






Clodagh Nerney | Tel: +353 (0) 1 507 9254