Senior Qualification- and Validation Specialist, 40 - 100%

Canexis Pharma AG is a Swiss company in pharmaceutical active ingredient manufacturing with a focus on cannabinoids. As a GMP-certified manufacturer, we specialize in the production, refinement, and processing of cannabis extracts and cannabis-APIs and supply customers worldwide.

Quality, trust, reliability, transparency, sustainability, and expertise characterize our actions. For the further development of our company and our vision to become a globally leading manufacturer of cannabis-APIs, we are looking for a long-term thinking personality to strengthen our team.

The newly created position offers the opportunity to actively shape the role.

Senior Qualification- and Validation Specialist, 40 - 100%

What we offer:

Dynamic company with flat hierarchies, insight into pharmaceutical active ingredient and bulk finished medicinal product production, opportunity to help shape exciting business and market developments, continuing education opportunities, annual working hours and flexitime, gross annual salary approx. 105‘000 CHF at a full-time workload

Tasks and responsibility:

• Planning, execution, and documentation of qualifications for plants, equipment, and infrastructure
• Creation and maintenance of qualification and validation documents (URS, RA, DIOQ, PQ)
• Execution and evaluation of process validations, cleaning validations, requalifications, and periodic reviews
• Ensuring the validated or qualified state throughout the entire lifecycle
• Evaluation of changes, deviations, and CAPA measures
• Support in the GMP-compliant validation of computer-aided systems (ERP/eQMS)
• Support during audits, inspections, and training
• Collaboration with internal and also external specialist departments on quality-relevant topics
• Support in regulatory matters such as product registrations
• Maintenance and evaluation of Continuous Process Verification (CPV) data
• Participation in process improvements and the implementation of corresponding measures

Your profile:

• Pharmaceutical or natural science basic training, university degree an advantage
• At least 5 years of experience in the GMP environment, preferably in qualification and validation
• Familiar with PIC/S PI 006-4 and EU-GMP Annex 15, profound experience in qualification, process, and cleaning validation
• Experience in active ingredient manufacturing, pharmaceutical production, or quality control an advantage
• Experience with controlled substances (narcotics) an advantage
• Very good German skills and business fluent English
• High awareness of quality, hygiene, and accuracy
• Structured, independent, pragmatic, and solution-oriented way of working as well as enjoyment of interdisciplinary cooperation

Have we aroused your interest? Then we ask you to send us your application documents electronically.

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