QC Chemist

Role Summary:

• Our client based in Co. Waterford is looking for QC Chemists to join their busy biopharmaceutical facility.
• The successful candidate will provide analytical chemistry services and support to site.

Core Duties and Responsibilities:

• Effective interaction with other departments on matters related to raw materials, intermediates and finished batch releases. In particular, close contact maintained with Quality Assurance Production, Engineering and Planners.
• Maintain, update and issue chemical methods, specifications and SOPs in compliance to pharmacopeial 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

Minimum Qualifications and Experience:

• Degree in Science (Chemistry or Biochemistry preferred).
• Post- graduate studies as appropriate to augment primary degree.
• Minimum 2-3 years experience working in a manufacturing environment preferred – ideally part of which would be in the pharmaceutical sector.

Please note, we do not require agency assistance with this role.