Qualification Engineer - Drug Substance & CSV (GMP)

Randstad Switzerland; Basel; Hybrid; CHF 110.000 - 140.000; Vollzeit

Zusammenfassung

Randstad Switzerland is seeking a Qualification Engineer in Drug Substance for Basel, with 1 year duration. The role requires hands-on equipment qualification and CSV work within GMP environments, including process systems and utilities.

English and German language skills are essential, and a degree in natural sciences or engineering is expected. The ideal candidate will manage QPPs, VMPs, and qualification reports, perform end-to-end qualifications, and support regulatory inspections.

Qualifikationen

• Experience in qualification/validation of equipment and CSV
• Hands-on experience qualifying/validating equipment and systems
• Strong understanding of GMP principles and data integrity

Aufgaben

• Create Qualification Project Plans (QPPs), and Validation Master Plans (VMPs)
• Author qualification/validation plans and reports across all phases
• Execute qualifications/validations per Quality System
• Evaluate changes affecting qualified status and manage requalification
• Document GMP-compliant tasks and summarize any deviations
• Develop proposed solutions for deviations and assist with electronic QA tools

Kenntnisse

GMP experience

Data Integrity

German language

English language

Ausbildung

Degree in natural sciences/engineering

Tools

CSV software

Jobbeschreibung

Randstad Switzerland is seeking a Qualification Engineer in Drug Substance for Basel, with 1 year duration. The role requires hands-on equipment qualification and CSV work within GMP environments, including process systems and utilities.

English and German language skills are essential, and a degree in natural sciences or engineering is expected. The ideal candidate will manage QPPs, VMPs, and qualification reports, perform end-to-end qualifications, and support regulatory inspections.