A QC Chemist is required for a biopharmaceutical company in Waterford. The incumbent will perform chemical testing following approved methodology to assure that the safety, quality, purity and stability of the products and in-process stages are in compliance with approved specifications. Provide analytical chemistry services and support to Site.
- Effective interaction with other departments on matters related to raw materials, intermediates and finished batch releases.
- Close contact maintained with Quality Assurance Production, Engineering and Planners.
- Maintain, update and issue chemical methods, specifications and SOP’s in compliance to pharmacopoeia and regulatory requirements.
- 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 required.
- Audit and review chemistry test results on a daily basis and ensure compliance with cGLP.
- Checking/auditing laboratory notebooks and analytical reports.
- Ensure compliance to cGMP at all times.
Qualifications & Experience:
- Degree in Science ( Chemistry or Biochemistry preferred).
- Postgraduate studies as appropriate to augment primary degree.
- 2-3 years experience working in a manufacturing environment preferred.
To apply for this job email your details to firstname.lastname@example.org.