Qualification Engineer in Drug Substance

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

We are supporting our client in the life sciences industry with their search for a Qualification Engineer Drug Substance.

If you have experience in plant qualification in the field of Drug Substance (API manufacturing) and in the field of Computer System Validation (CSV) this might the the perfect opportunity for you!

Responsibilities:

• Creating concepts, QPP (Qualification Project Plan) or VMP (Validation Master Plan)
• Creation of qualification/validation plans/reports for all phases
• Conducting qualifications/validations in all phases according to the business quality system
• Assessment of technical changes to plants with regard to their impact on the qualified condition and independent handling of requalification activities
• GMP-compliant documentation of the work performed and summary of any deviations that occurred.
• Documented and present changes and deviations during regulatory inspections, along with the equipment qualification and CSV documentation

Requirements:

• Degree in a natural science/engineering
• At least 3 years of professional experience in qualification processes
• Experience in the qualification of production facilities and the validation of computer systems
• Familiar with the practical implementation of GMP guidelines
• Practical professional experience with qualifications/CSV of various types of equipment/systems and rooms / media
• Several years of experience in the GMP field with in-depth understanding of quality systems and the lean implementation of GMP requirements
• Good knowledge of the topic "Data Integrity"
• Excellent German skills (spoken and written), good English skills

Please note that we can only consider EU/Schengen applications, or valid Swiss permit.