QC Chemist

Summary:
A QC Chemist is required for a biopharmaceutical company in Waterford. The incumbent will perform chemical testing following approved methodology to assure that the safety, quality, purity and stability of the products and in-process stages are in compliance with approved specifications. Provide analytical chemistry services and support to Site.

Responsibilities:

• 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.
• Maintain, update and issue chemical methods, specifications and SOP’s in compliance to pharmacopoeia 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.

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.