Deviation Manager

Proclinical is seeking a Deviation Manager to join a team focused on managing and investigating deviations within a large-scale mammalian cell culture facility. This role involves identifying root causes, assessing impacts, and implementing corrective actions to ensure compliance and continuous improvement.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities:

• Own, author, and investigate deviations in the manufacturing process.
• Collaborate with Subject Matter Experts (SMEs) and stakeholders to determine root causes and impacts.
• Utilize investigational tools like Fault Tree Analysis and Fishbone Diagrams to analyze deviations.
• Define and implement Corrective and Preventive Actions (CAPAs) and effectiveness checks.
• Ensure compliance with cGMP standards throughout the investigation process.
• Support ongoing change and process improvement initiatives.

Key Skills and Requirements:

• Degree in chemistry, biotechnology, life sciences, or a related field.
• Familiarity with deviations and cGMP in a regulated pharmaceutical/API environment is beneficial.
• Understanding of biotech manufacturing processes and analytical methods is advantageous.
• Experience with risk management and Human and Organizational Performance approaches is a plus.
• Proficiency in English; German language skills are a bonus.
• Strong technical writing and communication skills.
• Ability to work independently and lead teams without formal authority.
• Organized, open-minded, and motivated with a focus on continuous improvement.

If you are having difficulty in applying or if you have any questions, please contact Ashley Bennett at a.bennett@proclinical.com.

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.