Qualification Expert

Qualification Expert - GMP/Validation/Siemens COMOS/EVAL/Veeva/English/German

Project / Role:
For our customer a big pharmaceutical company in Basel we are looking for a highly qualified Qualification Expert (m/f/d).

Background:
The Qualification Unit of Engineering and SHE at the Kaiseraugst site is seeking reinforcement for the qualification of Embedded Systems. Embedded Systems are production facilities with embedded process automation systems, such as SCADA/HMI. For a successful production site in Kaiseraugst, we drive progress through scientific and technical expertise and proactive service. We achieve this through continuous improvement of our processes, an agile workforce, and a lot of passion.

The perfect candidate: The perfect candidate is an experienced qualification expert with several years of hands-on experience in qualification within a GMP environment, preferably the pharmaceutical industry.

Main Tasks:
• Responsible for planning and conducting qualification and validation activities
• Creating and reviewing qualification and validation documents (DQ, IQ, OQ, PQ)
• Carrying out and documenting qualification processes for our Embedded Systems / process automation systems according to cGMP
• Developing, implementing, and conducting test strategies, test plans, and test cases to verify system performance and compliance
• Providing expertise in creating specifications (e.g., URS).
• Working with IT, process engineering / automation, quality assurance, and production departments to ensure smooth integration and qualification of the systems.
• Handling qualification impact assessments as part of change or deviation process management.
• Collaborating closely and communicating intensively with other departments
• Providing assistance in the processing of deviations, changes and CAPAs

Must Haves:
• Technical degree in a relevant field
• Further training and hands-on experience in the area of GMP
• Min. 3-5 years of experience in the qualification and validation of machines and processes, preferably in the pharmaceutical industry
• Several years hands on work experience in qualification
• Experience with Siemens COMOS, EVAL (ValGenesis) and VEEVA
• Fluency in German spoken and written needed, English fluency written and reading comprehension
• Very independent and structured way of working with a self-image of self and to continuously improve the processes
• High degree of initiative, flexibility and quick comprehension skills
• Enthusiasm for working together in self-organized teams and for your own areas of responsibility areas of responsibility with a focus on the big picture

Reference No.: 924111SDA
Role: Qualification Expert
Industry: Pharmaceutical
Location: Kaiseraugst
Workload: 100%
Start: ASAP
Duration: 12++

Should you find yourself suitable for this position, please send us your complete CV using the link in this advert. If the position is not a perfect match and you wish to receive other opportunities directly, you can send us your CV anyway via this advert or to jobs[at]itcag[dot]com.

Contact us for further information regarding our company, our positions or our attractive payroll-only-program: +41 41 760 77 01.

About us:
ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and Ireland. Specializing in delivering IT candidates for contract work, we understand the importance of professional support in your search for a new project. Established in 1997 by IT professionals, we are committed to your success.