Role Purpose:
* A fantastic new opportunity has arisen for an Analytical Sciences & Technology (AST) Analyst to join our client’s busy biopharmaceutical facility in Co. Waterford.
* The AST Analyst will participate in the delivery of analytical projects as pertaining to business needs.
* The successful candidate will ensure current Good Laboratory Practices (cGLP) is adhered to in all areas of work.
* To create and maintain a safe work environment and report any unsafe conditions observed in the workplace.
Core Duties and 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, particularly maintaining close contact 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 updates on the ongoing projects and identify improvements when needed.
* Participate in analytical and functional method improvements, manage and give updates on ongoing activities.
* Bring innovative ideas and actively research for improvements around the analytical space.
* Support other functions in investigations and troubleshooting as required.
* Assist with training of analysts 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 using 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 and 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.
Education & Qualifications Required:
* Degree in Science (Chemistry or Biochemistry preferred).
* Experience in a laboratory environment – ideally part of which would be in the pharma or biopharma sector.
* Minimum 1 year of experience in a similar role required.
* 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.
* Understanding of relevant quality/compliance regulations.
* Ability to manage projects to plan and budget.
* Understanding of Key Performance Indicators (KPI’s) for the site.
* Good communication and facilitation skills.
* Ability to work independently.
* Shows flexibility, drive, and innovation.
* Dedication to adherence to business needs.
* Effective collaboration with other functions and the AST team.
* Eagerness to learn new techniques.
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