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QTA Analyst x8
QTA Analyst x8 - Waterford
Alexander Mann Solutions (AMS) is the world’s leading provider of Talent Acquisition and Management Services. We deliver award-winning solutions to over 65 outsourcing clients and consulting services to hundreds more. Our Contingent Workforce Solutions (CWS) service acts as an extension of our clients’ recruitment team and provides professional interim and temporary resources.
Genzyme - Sanofi Genzyme, the specialty care business unit of Sanofi, focuses on rare diseases, multiple sclerosis, oncology, and immunology. We help people with debilitating and complex conditions that are often difficult to diagnose and treat. Our approach is shaped by our experience developing highly specialized treatments and forging close relationships with physician and patient communities. We are dedicated to discovering and advancing new therapies, providing hope to patients and their families around the world
On behalf of our client, we are currently looking for 8 QTA Analyst roles for a 12 month contract based in Waterford.
* 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
Compliance Related Tasks
* 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
* Degree in Science (Chemistry or Biochemistry preferred). Post-graduate studies as appropriate to augment primary degree.
* Graduate – previous experience not essential but beneficial. 2-3 years’ experience working in a manufacturing environment preferred – ideally part of which would be in the pharmaceutical sector.
Skills & Knowledge
* Operational experience of quality laboratories in a fast moving manufacturing environment. * Detailed knowledge of quality management systems, pharmaceutical manufacturing operations, requirements for cGLP, pharmacopoeial methods and stability. * Understand relevant quality/compliance regulations. * Can manage projects to plan/budget. * HLPC Experience * GMP Knowledge * Understands KPI’s for the site
If you are interested in sending your CV and meet the criteria outlined above, please click the link to apply and speak to one of our sourcing specialists now