
Quality Control Analyst
12 hours ago
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 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.
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.
Skills: HPLC GMP Karl Fisher SDS-PAGE ELISA
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