Deviation Specialist

For a biopharmaceutical company based in Visp, our team is looking for a Deviations Specialist to strengthen its quality activities in GMP environment.

- Contract : Temporary

- Start date : Beginning of August

- Duration : 5 months

Primary mission :

The Deviations Specialist is responsible for the management, investigation and closure of deviations occurring in a GMP biopharmaceutical environment, particularly within a large-scale mammalian cell culture facility. He/she acts as the representative of Operations and ensures the identification of root causes, the evaluation of quality impacts, and the implementation of effective CAPA.

• Write, record, track, and close quality deviations.

• Ensure document compliance throughout the deviation’s life cycle.

• Ensure compliance with processing and closing times.

• Conduct investigations to identify root causes and contributing factors.

• Collaborate with business experts (SME) and relevant stakeholders.

• Assess the actual or potential impact on products, processes, equipment, or quality systems.

• Use structured problem-solving methodologies (root cause analysis, quality risk management tools)

• Define and implement corrective and preventive actions.

• Establish efficiency criteria and controls.

• Monitor the execution of CAPAs to prevent recurring events.

• Participate in change and process optimization projects.

• Contribute to strengthening the quality culture and GMP compliance.

• Support operational improvement initiatives.

Profile :

• Bachelor’s degree in Chemistry, Biotechnology, Life Sciences or equivalent scientific field.

• First experience in deviation management and GMP/cGMP environment within the pharmaceutical, biotechnology, or API industry, highly appreciated.

• Knowledge of biotechnological manufacturing processes and associated analytical methods.

• Experience in root cause analysis, risk management, and Human & Organizational Performance (HOP) approaches is an asset.

• Excellent command of English (spoken and written); German is a plus.

• Strong writing, analytical and communication skills.

• Organized person, rigorous, proactive and solution-oriented, able to work effectively with multidisciplinary teams in a dynamic and regulated environment.

• English: fluent (written and oral), German is a must.