Qualification Engineer – Drug Substance & CSV

Actalent; Basel; Vor Ort; CHF 90.000 - 140.000; Vollzeit

Zusammenfassung

Actalent is supporting a client in the life sciences industry by searching for a Qualification Engineer Drug Substance. The role focuses on plant qualification for Drug Substance (API manufacturing) and Computer System Validation (CSV).

You will develop Qualification Project Plans, qualification/validation reports, and conduct GMP-compliant qualifications while ensuring data integrity and adherence to quality systems.

Qualifikationen

• Degree in a natural science/engineering.
• At least 3 years of professional experience in qualification processes.
• Experience in qualification of production facilities and validation of computer systems.
• Familiar with GMP guidelines implementation.
• Experience with qualifications/CSV of equipment/systems and rooms/media.
• Several years in GMP with understanding of quality systems and lean GMP requirements.
• Good knowledge of Data Integrity.
• Excellent German (spoken and written) and good English.

Aufgaben

• Creating concepts, QPP or VMP for qualification projects.
• Creation of qualification/validation plans and reports for all phases.
• Conduct qualifications/validations in all phases per the quality system.
• Assess technical changes to plants and manage requalification activities.
• GMP-compliant documentation and deviation summaries.
• Present changes and deviations during regulatory inspections with CSV documentation.

Jobbeschreibung

Actalent is supporting a client in the life sciences industry by searching for a Qualification Engineer Drug Substance. The role focuses on plant qualification for Drug Substance (API manufacturing) and Computer System Validation (CSV).

You will develop Qualification Project Plans, qualification/validation reports, and conduct GMP-compliant qualifications while ensuring data integrity and adherence to quality systems.