2025-1273- Analytical Sciences & Technology Analyst-Waterford Contractor

Purpose:

To participate in delivery of analytical projects as pertaining to business needs. To ensure current Good Laboratory Practices cGLP is adhered to in all areas of work.To create and maintain safe work environment and report any unsafe conditions observed in the workplace.

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.

Qualifications:

• 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.
• Good communication and facilitator skills
• Ability to work independently
• Shows flexibility, drive, and innovation
• Dedication to adherence to business needs
• Effective collaboration with other functions and AST team
• Eagerness to learn new techniques