Role Overview
This is a 12-month contracting position as an Analytical Chemist in Waterford, Ireland. The successful candidate will work closely with our pharmaceutical client to provide analytical chemistry services and support.
* 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.
* Interact effectively with other departments on matters related to raw materials, intermediates, and finished batch.
* 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 and in 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.
* Ensure that critical chemical testing and related equipment meets current validation requirements (IQ, OQ, PQ).
* Audit and review chemistry test results on a daily basis and ensure compliance with cGLP.
* Check laboratory notebooks and analytical reports.
Requirements and Qualifications
* 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.