Senior Qualification and Validation Specialist, 40 - 100%

About the job

Canexis Pharma AG is a Swiss company specialising in the manufacture of pharmaceutical active ingredients with a focus on cannabinoids. As a GMP-certified manufacturer, we specialise in the production, refinement, and processing of cannabis extracts and cannabis APIs, supplying customers worldwide.

Quality, trust, reliability, transparency, sustainability, and expertise shape our actions. To further develop our company and our vision of becoming a globally leading manufacturer of cannabis APIs, we are seeking a long-term minded individual 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 product manufacturing Opportunity to help shape exciting business and market developments Further training opportunities Annual working hours and flexitime Gross annual salary approx. CHF 105,000 for a full-time position

Tasks and responsibilities:

- Planning, execution, and documentation of qualifications for equipment, devices, and infrastructure
- Creation and maintenance of qualification and validation documents (e.g. 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 GMP-compliant validation of computerised systems (e.g. ERP/eQMS)
- Support during audits, inspections, and training sessions
- Collaboration with internal and external departments on quality-relevant topics
- Support with regulatory matters such as product registrations
- Maintenance and analysis of Continuous Process Verification (CPV) data
- Participation in process improvements and implementation of corresponding measures

Your profile:

- Pharmaceutical or scientific basic education, university degree advantageous
- At least 5 years of experience in a 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 advantageous
- Experience with controlled substances (narcotics) advantageous
- Very good German skills and business fluent English
- High awareness of quality, hygiene, and accuracy
- Structured, independent, pragmatic, and solution-oriented working style as well as enjoyment of interdisciplinary collaboration



Have we piqued your interest? Then please send us your application documents
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