Analytical Chemistry Specialist

4 days ago

Waterford, Waterford, Ireland beBeeChemistry Full time €50,000 - €80,000

Job Title: Chemical Expert

We are seeking a highly skilled and experienced Chemical Expert to join our team in providing analytical chemistry services.

Key Responsibilities:

  • Isolate particles from sterile biologics and investigate their origin using techniques such as FTIR, scanning electron microscopy, and RAMAN spectroscopy.
  • Provide analytical chemistry services and support to the site, including close contact with Quality Assurance, Production, Engineering, and Planners.
  • Maintain, update, and issue chemical methods, specifications, and SOPs in compliance with pharmacopoeial and regulatory requirements.
  • Assist with training of analysts in areas of expertise and knowledge, as well as new methods, SOPs, and updates.
  • Trend results, record on COAs where required, and complete OOS investigations on a timely basis.
  • Update the QC Team Leader on potential problems and highlight improvements where possible.
  • Ensure all quality documentation and records are complete and current.
  • Ensure QC laboratories meet current Good Laboratory Practice (cGLP) requirements.
  • Ensure relevant procedures are correctly defined and followed.
  • Audit and review chemistry test results on a daily basis and ensure compliance with cGLP.

Requirements:

  • 4 years' experience in the Medical Device Industry.
  • Minimum of a 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.

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