2023-796-QC Chemist-Waterford Contractor

Purpose:

Provide analytical chemistry services and support to the 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.

Responsibilities:

• Maintain, update and issue chemical methods, specifications, and SOP’s in compliance with pharmacopoeial 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 the 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 meet 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 with cGMP at all times.

Minimum Qualifications & Requirements:

• 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.