Qualification and CSV Expert (m/f/d)

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.