Roche Switzerland bridges the gap between pharmaceuticals and diagnostics. Important research and development functions are located here. For our long-term client, F. Hoffmann-La Roche AG in Kaiseraugst, we are looking for a
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, they drive progress through scientific and technical expertise and proactive service. They achieve this through continuous improvement of the processes, an agile workforce, and a lot of passion.
Tasks & Responsibilities:
- 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 CSV/automation
- Experience with Siemens COMOS, EVAL (ValGenesis) and VIVA
- 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
What you will be offered:
- An opportunity to work in one of the world's most important pharmaceutical companies
- Modern campus with plenty of green spaces and meeting areas
- Central location in Basel
- Varied job profile
- Further training opportunities through temptraining
- Working in a dynamic and motivated team
If you are interested please send your application documents addressed to Ms Diana Afonso.
Basel-Stadt Labor Laboratory Qualification Expert Validation GMP