For our client, an international pharma company in Kaiseraugst, we are looking for a
Qualification and CSV Expert
to support qualification of embedded systems.
General Information:
* Start date: ASAP
* Planned duration: 2 years
* Extension: likely
* Contract: temporary contract via Randstad
* Workplace: Kaiseraugst
* Workload: 100%
* Home Office: up to 20%
* Working hours: Standard
Tasks & Responsibilities:
* Implementation and documentation of qualification processes for our embedded systems / process automation systems according to cGMP.
* Development, implementation, and execution of test strategies, test plans, and test cases to verify system performance and compliance.
* Technical participation in the creation of specifications (e.g., URS)
* Collaboration with the IT, Process Engineering/Automation, Quality Assurance, and Production departments to ensure smooth integration and qualification of systems.
* Creation and maintenance of qualification documentation (DQ, IQ, OQ, PQ) and supporting design documents such as data flow diagrams and audit trail review assessments.
* Processing of qualification impact assessments as part of change or deviation process management.
* A proactive and self-reflective approach to working in expert teams.
Must Haves:
* Degree in a natural sciences/engineering program or relevant professional experience.
* At least 3 years of professional experience and in-depth experience in the qualification process and CSV
* Fluent in English and German
* Practical professional experience with qualifications and validation of various types of systems
* Several years of experience in the GMP field with a deep understanding of quality systems and the lean implementation of GMP requirements
* Profound experience in strategic and conceptual work, with strong project management and self-management skills
* Good documentation practices in a GMP environment
Nice to have:
* Practical experience with common process control systems (e.g., Siemens Simatic)
* In-depth knowledge of regulatory frameworks (ICP, GMP Guidelines including Annex 11, Annex 22)
* Experience in fully electronic qualification (Val genesis)
Soft skills:
* Highly independent and structured working style with the commitment to continuously improving oneself and one's processes
* High degree of initiative, flexibility, and rapid response comprehension skills
* You are characterized by a solution-oriented approach and can find practical solutions even in complex situations.
* Good communication skills for efficient teamwork
* Team spirit, enthusiasm for cross-functional collaboration, and the ability to actively contribute to a positive working environment.