QC Chemist

Role Purpose:

• Our client, based in Co. Waterford, is looking for a QC Chemist to join their busy biopharmaceutical facility.
• The QC Chemist will be providing 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 pharmacopoeial and regulatory requirements
• Assist with training of the analysts in areas of expertise and knowledge and in new methods, SOPs and updates
• Trend such results, record on COAs where required and complete OOSs 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

Education & Qualifications Required:

• 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

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