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).
* Postgraduate studies as appropriate to augment primary degree
* Minimum 2-3 years’ experience working in a manufacturing environment with experience in the following testing methods UV, KF, HIAC, SDS Page and HPLC.
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