QC Analyst

7 days ago

Waterford, Waterford, Ireland Cpl Full time

We are currently seeking a QC Analyst with previous industry experience to join our client's site in Waterford on an initial 12 months contract.

Key responsibilities:


• Provide analytical chemistry services and support to Site.


• 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 SOP's in compliance to 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 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:


• Degree in Science (Chemistry or Biochemistry preferred). Postgraduate studies as appropriate to augment primary degree.


• 2-3 years experience working in a manufacturing environment – ideally part of which would be in the pharmaceutical sector.


• Experience with some of the following tests: HPLC/UPLC, SDS-PAGE, Karl Fischer, HIAC, micro pipetting and ELISA.

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