Elusav Recruitment have an amazing opportunity for a AST Analyst with a leading global biopharma company in Waterford, Ireland.
As the AST Analyst you will participate in the delivery of analytical projects as pertaining to business needs.
Responsibilities:
* Provide analytical chemistry expertise and support to AST-MSAT and the Site activities.
* Effective interaction with other departments on matters related to ongoing projects. In particular, close contact maintained with Quality Assurance, Quality Control, Manufacturing, Engineering and Program Leads.
* Participate in development, qualification, and method optimisation for the projects.
* Participate in method transfer activities as required.
* Provide update on the ongoing projects and identify improvements when needed.
* Participate in analytical and functional method improvements, manage and give update on ongoing activities.
* Bring innovative ideas and actively research for improvements around the analytical space.
* Support other functions in investigations, troubleshooting, as required.
* Assist with training of the analyst in areas of expertise and knowledge and in new methods, and techniques.
* Update the AST Team Leader on potential problems and highlight improvements where possible by use of the normal communication means.
* Ensure all quality documents and records are complete and current.
* Ensure laboratory areas meet current Good Laboratory Practices (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.
* Ensure safety & compliance standards are maintained to the highest standards.
* Maintain internal / external audit ready standards.
* Maintain training compliance.
* Maintain Good Documentation Practices (GDP) at all times including laboratory notebooks and analytical reports.
* Ensure compliance to current Good manufacturing Practices (cGMP) at all times.
Requirements:
* Degree in Science (Chemistry or Biochemistry preferred).
* Experience in a laboratory environment – ideally part of which would be in the pharma or biopharma sector.
* Experience leading people or projects.
* Operational experience of quality laboratories in a fast-moving manufacturing environment.
* Knowledge of quality management systems, pharmaceutical manufacturing operations, requirements for cGLP, pharmacopeial methods and stability.
* Understand relevant quality / compliance regulations.
* Ability to manage projects to plan and budget.
* Understanding Key Performance Indicators (KPI’s) for the site.
Contact:
If you would like to learn more about the vacancy, apply now, or contact Thaissa Torres on Ttorres@elusav.com or +35315822807.
#J-18808-Ljbffr