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 a safe work environment and report any unsafe conditions observed in the workplace.
Responsibilities
1. Provide analytical chemistry expertise and support to AST-MSAT and the Site activities.
2. Effective interaction with other departments on matters related to ongoing projects, maintaining close contact with Quality Assurance, Quality Control, Manufacturing, Engineering, and Program Leads.
3. Participate in development, qualification, and method optimisation for the projects.
4. Participate in method transfer activities as required.
5. Provide updates on ongoing projects and identify improvements when needed.
6. Participate in analytical and functional method improvements, manage and give updates on ongoing activities.
7. Bring innovative ideas and actively research for improvements around the analytical space.
8. Support other functions in investigations and troubleshooting as required.
9. Assist with training of analysts in areas of expertise and knowledge and in new methods and techniques.
10. Update the AST Team Leader on potential problems and highlight improvements where possible.
11. Ensure all quality documents and records are complete and current.
12. Ensure laboratory areas meet current Good Laboratory Practices (cGLP) requirements.
13. Ensure relevant procedures are correctly defined and followed.
14. Ensure that critical chemical testing and related equipment meet current validation requirements (IQ/OQ/PQ) where required.
15. Ensure safety and compliance standards are maintained to the highest standards.
16. Maintain internal/external audit-ready standards.
17. Maintain training compliance.
18. Maintain Good Documentation Practices (GDP) at all times, including laboratory notebooks and analytical reports.
19. Ensure compliance with current Good Manufacturing Practices (cGMP) at all times.
Qualifications
1. Degree in Science (Chemistry or Biochemistry preferred).
2. Experience in a laboratory environment, ideally part of which would be in the pharma or biopharma sector.
3. Experience leading people or projects.
4. Operational experience of quality laboratories in a fast-moving manufacturing environment.
5. Knowledge of quality management systems, pharmaceutical manufacturing operations, requirements for cGLP, pharmacopeial methods, and stability.
6. Understanding of relevant quality/compliance regulations.
7. Ability to manage projects to plan and budget.
8. Understanding Key Performance Indicators (KPIs) for the site.
9. Good communication and facilitation skills.
10. Ability to work independently.
11. Shows flexibility, drive, and innovation.
12. Dedication to adherence to business needs.
13. Effective collaboration with other functions and the AST team.
14. Eagerness to learn new techniques.
Skills:
Analytical Projects, MSAT, Method Transfers, Lab Experience
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