Quality Assurance Expert Analytics, Drug Product Services - 12 months fix-term contract 80-100%

Tasks

• Act as last approver for deviations
• Approve specifications in LIMS
• Conduct OOS investigations
• Ensure adherence to GMP for stability studies
• Ensure staff qualification
• Establish and maintain quality management system
• Provide GMP compliance guidance for projects
• Review and approve analytical methods
• Review and approve analytical reports
• Review and approve qualification validation transfer protocols
• Serve as compliance first contact for LIMS
• Supervise GMP compliance activities

Perks/Benefits

• Agile career development
• Compensation programs
• Ethical workplace
• Inclusive workplace

Skills/Tech-stack

Analytical SOPs | Analytical method validation | Biological Drug Product Testing | CGMP | Deviation Management | EU GMP | GMP | LIMS | Management System | Method validation | Out of Specification | Out of Specification Investigations | Product Testing | Qualification | Quality Management System | Quality management | Transfer protocols | US GMP | Validation