The role involves planning and executing comprehensive audits for the organization, subcontractors, and suppliers in compliance with internal SOPs and bioanalytical method validation guidelines
Job Summary
The role involves planning and executing comprehensive audits for the organization, subcontractors, and suppliers in compliance with internal SOPs and bioanalytical method validation guidelines.
Candidates will be responsible for reviewing raw data against draft reports to ensure accuracy and conducting operational spot inspections while monitoring corrective actions.
The position requires maintaining current knowledge of international standards including GCLP, GCP, GMP, CAP, ISO17025, and ISO 15189 while acting as a primary contact for quality questions.
Matching Summary
Match Score: 85
The role involves planning and executing comprehensive audits for the organization, subcontractors, and suppliers in compliance with internal SOPs and bioanalytical method validation guidelines.
Skills & Requirements
Must-have
Plan and execute audits according to timetable
Review raw data against draft reports
Conduct in-life phase inspections
Monitor corrective measures implementation
Maintain knowledge of GCLP, GCP, GMP guidelines
Nice-to-have
Strong affinity with quality systems setup
Confident engagement with management
Ability to increase quality consciousness
Continuous focus on improvement optimization
Organizational talent under pressure
Key Requirements
Bachelor degree in Life Science or Quality oriented education