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Senior Chemistry Professional

3 weeks ago


Waterford, Waterford, Ireland beBeeAnalyticalchemist Full time €70,000 - €95,000

Job Overview

An Analytical Chemist plays a pivotal role in ensuring the quality and purity of pharmaceutical products. This 12-month contracting position involves working closely with the Quality Assurance team to ensure compliance with Good Laboratory Practice (cGLP) requirements.

Key Responsibilities:
  • Isolate particles from sterile biologics and investigate their origin using advanced techniques such as FTIR, scanning electron microscopy, and Raman spectroscopy.
  • Provide analytical chemistry services and support to the Site, including maintaining and updating chemical methods, specifications, and SOPs.
  • Develop and implement effective communication strategies to collaborate with other departments on matters related to raw materials, intermediates, and finished batches.
  • Train analysts in areas of expertise and knowledge, including new methods, SOPs, and updates.
  • Trend results, record COAs, and complete OOS investigations in a timely manner.
  • Ensure all quality documentation and records are complete and current, adhering to cGLP requirements.
  • Audit and review chemistry test results daily, ensuring compliance with cGLP.
  • Verify laboratory notebooks and analytical reports for accuracy and completeness.

Requirements:

  • 4 years' experience in the Medical Device Industry.
  • Primary degree in an Engineering or Technical Discipline.
  • Experience in Process characterization, Validation, and statistical methods.
  • Meticulous attention to detail with a methodical and analytical approach to problem-solving.