QC Chemist

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.
• Postgraduate studies as appropriate to augment primary degree.
• 2-3 years’ experience working in a manufacturing environment preferred.