Job Opportunity
An Analytical Chemist is required for our pharmaceutical client.
About the Role:
1. You will be responsible for isolating particles from sterile biologics and determining their origin using advanced analytical techniques, such as FTIR, scanning electron microscopy, and RAMAN spectroscopy.
2. Provide analytical chemistry services and support to the site, including effective interaction with other departments on matters related to raw materials, intermediates, and finished batches.
3. Maintain, update, and issue chemical methods, specifications, and SOPs in compliance with pharmacopoeial and regulatory requirements.
4. Assist with training analysts in areas of expertise and knowledge and in new methods, SOPs, and updates.
5. Trend results, record COAs where required, and complete OOS investigations on a timely basis.
6. Update the QC Team Leader on potential problems and highlight improvements where possible.
7. Ensure all quality documentation and records are complete and current.
8. Ensure QC laboratories meet current Good Laboratory Practice (cGLP) requirements.
9. Ensure relevant procedures are correctly defined and followed.
10. Audit and review chemistry test results on a daily basis and ensure compliance with cGLP.
11. Checking/auditing laboratory notebooks and analytical reports
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.
* The ability to work 3 days on site and 2 days remotely.