Qualification Engineer - Drug Substance

For our client, an international pharma company in Basel, we are looking for a Qualification Engineer with experience in plant qualification in the field of Drug Substance (API manufacturing).

The work environment includes process plants, media, energy, and air conditioning systems such as reactors, fermenters, centrifuges, pure water, steam, autoclaves, clean rooms, and small parts washing machines.


General Information:

• Start date: open
• Planned duration: 5 years
• Contract: temporary via Randstad
• Workplace: Basel
• Workload: 80-100%
• Home Office: possible up to 2 days/week
• Working hours: Standard

Tasks & Responsibilities:
 

• Preparation of qualification plans/reports for the DQ-IQ-OQ-PQ phases according to the Quality System.
• Conducting qualifications in the DQ-IQ-OQ-PQ phases according to the Quality System.
• Preparation of QPPs (Qualification Project Plans).
• Evaluation of technical changes to systems with regard to their impact on the qualified status and independent processing of requalification activities.
• GMP-compliant documentation of the work performed and summary of any deviations encountered.
• Development of proposed solutions for the deviations encountered.
• Familiarization with electronic qualification and validation software.

Must Haves:
 

• Degree in a natural sciences/engineering program or relevant professional experience.
• At least 3 years of professional experience and solid experience in the qualification process
• Fluent in German, good English skills
• Practical professional experience with the qualification of various types of systems and rooms/media
• Several years of experience in the GMP field with a deep understanding of quality systems and the lean implementation of GMP requirements
• Initial experience with data integrity is desirable