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Job Description
Join an award-winning pharmaceutical organization in Waterford.
Analyze chemistry services and support Site, interacting with departments on raw materials, intermediates and finished batch releases.
- Maintain, update and issue chemical methods, specifications and SOPs in compliance to pharmacopoeial and regulatory requirements
- Assist with training of analysts in areas of expertise and knowledge
- Trend results, record on COAs and complete OOSs investigations
- Audit and review chemistry test results daily
Requirements:
- Relevant laboratory experience in a manufacturing environment
- Operational experience of quality laboratories in a fast-moving manufacturing environment
- Knowledge of quality management systems, pharmaceutical manufacturing operations, cGLP, pharmacopoeial methods and stability
- Knowledge of HPLC, ICIEF, CE-SDS methodologies
- Understanding of quality/compliance regulations and KPIs
Education: Degree in Science (Chemistry or Biochemistry preferred)
Qualifications: Batch Release Chemistry QC Sterile GMP HPLC