Deviation Specialist Opportunity
For one of our esteemed pharmaceutical clients based in Visp, we are seeking a highly motivated Deviation Specialist (m/f/d) to join their dedicated team. This position is critical to the operations of a large-scale mammalian cell culture facility, where the successful candidate will take ownership of investigating and managing deviations.
Role Overview
The Deviation Specialist will represent the Operations Unit, tackling deviations that arise by investigating the root causes, assessing their impact on products and/or systems, and defining appropriate corrective and preventive actions (CAPA) as solutions.
Key Responsibilities
- Own, author, record, and investigate deviations.
- Liaise with Subject Matter Experts (SMEs) and key stakeholders to determine the root causes and potential impacts of deviations.
- Utilize effective investigational tools to systematically identify root causes and contributing factors (e.g., Fault Tree Analysis, Defense Analysis, Event & Causal Factors Chart, Fishbone Diagram, etc.).
- Contribute to the development of appropriate CAPAs and associated Effectiveness Checks to rectify deviations and prevent future occurrences.
- Ensure compliance with current Good Manufacturing Practices (cGMP) throughout the investigation process, driving quality records to completion and timely closure.
- Support the business in ongoing change and process improvement initiatives.
Key Requirements
- Bachelor's degree in Chemistry, Biotechnology, Life Sciences, or a related field.
- Previous experience with deviations and cGMP in a regulated pharmaceutical/API industry is a significant advantage.
- Familiarity with biotech manufacturing processes and analytical methods is a plus.
- Experience with Human and Organizational Performance and risk management approaches is beneficial.
- Fluency in English, both written and spoken; proficiency in German is an advantage.
- Exceptional technical writing, presentation, and communication skills are essential for this role.
- A structured, focused, and well-organized work ethic, combined with an open-minded approach to new ideas and suggestions.
- Highly motivated and dynamically driven individual.
Apply online using the form below. Only applications matching the job profile will be considered.
Contact Information
If you have any questions, please reach out to:
Alba Jansa
Email: alba.jansa@experis.ch
Phone: +41 61 282 22 13