
Website TPM04995
Summary:
Our client, a bio pharmaceutical company located in Waterford, is currently looking for a QC Chemist. The incumbent will be responsible for providing analytical chemistry services and maintaining, updating and issuing chemical methods, specifications and SOPs in compliance to pharmacopoeial and regulatory requirements.
Responsibilities:
- Effective interaction with other departments on matters related to raw materials, intermediates and finished batch releases.
- Assist with training of the Analysts in areas of expertise and knowledge and in new methods, SOPs 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 – Installation Qualification, OQ – Operational Qualification, PQ – Performance Qualification) 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).
- Post-graduate studies as appropriate to augment primary degree.
- Operational experience of quality laboratories in a fast moving manufacturing environment.
- Detailed knowledge of quality management systems, pharmaceutical manufacturing operations, requirements for cGLP, pharmacopoeial methods and stability.
To apply for this job email your details to lara.miranda-pinto@tandempm.ie.