Archiviertes Projekt - Qualification Expert (M/F/D)

Tasks:
• Qualifying and validating analytical equipment in Physical Chemistry and Bioanalytics Quality Control (QC) laboratories
• Drafting essential qualification documents such as User Requirement Specifications (URS), Risk Assessments, and Operational and Performance Qualification (OQ/PQ) Plans and Reports
• Evaluating and approving qualification/validation-related reports as necessary in compliance with cGxP standards
• Maintaining equipment in Physical Chemistry and Bioanalytics QC laboratories according to relevant Standard Operating Procedures (SOPs)
• Collaborating with cross-functional teams and stakeholders
• Serving as a subject matter expert for laboratory system qualification during audits and inspections

Qualification:
• Degree in fields such as Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Engineering, or equivalent practical experience as an Analytical Lab Technician
• Extensive background in qualifying analytical equipment and validating software
• Excellent understanding of relevant regulatory requirements related to analytical equipment qualification
• Familiarity with quality management systems (e.g., TrackWise) is advantageous
• Capability to thrive in a fast-paced environment
• Proficient in English language (both written and spoken)

Requirements:
Start: asap
Duration: Until end of the year ( extension highly possible)
Capacity: 5 days per week
Location: Basel