Jobdescription
For our client, a leading international pharmaceutical company in Switzerland, we are seeking aQualification Expert.
General Information:
* Start date:ASAP
* Duration:12 months, with the possibility of extension
* Workplace:Kaiseraugst
* Workload:100%
* Team:25 people
* Department:Qualification (MMMCGE)
* Working hours:Standard
* Remote/Home Office:max. 20%
About the job:
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.
Your Profile:
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.
Tasks & Responsibilities:
* Responsible for planning and conducting qualification and validation activities
* Creating and reviewing qualification and validation documents (DQ, IQ, OQ, PQ): (Design Qualification), (Installation Qualification), (Operational Qualification), (Performance Qualification).
* 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:
1. Technical degree in a relevant field
2. Further training and hands on experience in the area of GMP
3. Min. 3 5 years of experience in the qualification and validation of machines and processes, preferably in the pharmaceutical industry
4. Several years hands on work experience in qualification
5. Experience with CSV/automation
6. Experience with Siemens COMOS, EVAL (ValGenesis) and VIVA
7. Fluency in German spoken and written needed, English fluency written and reading comprehension
8. Very independent and structured way of working with a self image of self and to continuously improve the processes
9. High degree of initiative, flexibility and quick comprehension skills
10. Enthusiasm for working together in self organized teams and for your own areas of responsibility areas of responsibility with a fo