Analytical Chemist
- Waterford
- €40,000-50,000 per year
- Contract
- Full-time
- You will be Responsible for isolating particles from sterile biologics and informing the investigation as to the origin on the particle. Specifically, FTIR, scanning electron microscopy, RAMAN spectroscopy
- Provide analytical chemistry services and support to Site.
- Effective interaction with other departments on matters related to raw materials, intermediates and finished batch In particular, close contact maintained with Quality Assurance Production, Engineering and Planners.
- Maintain, update and issue chemical methods, specifications and SOP’s in compliance to pharmacopoeial and regulatory
- Assist with training of the analysts in areas of expertise and knowledge and in new methods, SOP’s and updates.
- Trend such results, record on COA’s where required and complete OOS’s investigations on a timely basis.
- Update the QC Team Leader on potential problems and highlight improvements where possible by use of the normal communication means.
- 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
- Ensure that critical chemical testing and related equipment meets current validation requirements (IQ, OQ, PQ) where
- Audit and review chemistry test results on a daily basis and ensure compliance with cGLP.
- Checking/auditing laboratory notebooks and analytical reports
- 4years’ 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.
- You would can to be based 3 days on site and 2 days remotely.
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