Join a high‑performing CMO where your scheduling expertise keeps site operations running with precision, efficiency, and flawless coordination.
Proclinical is seeking a Deviation Specialist to join a dynamic team focused on managing and investigating deviations within a large-scale mammalian cell culture facility. In this role, you will take ownership of deviation investigations, ensuring compliance with cGMP standards while driving quality records to completion. This position is ideal for someone passionate about problem-solving, process improvement, and contributing to high-quality manufacturing operations.
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, record, and investigate deviations within the facility.
- Collaborate with Subject Matter Experts (SMEs) and stakeholders to identify root causes and assess the impact of deviations.
- Utilize investigational tools such as Fault Tree Analysis, Fishbone Diagrams, and Event Causal Factors Charts to systematically analyze issues.
- Define and implement corrective and preventive actions (CAPAs) and effectiveness checks to address deviations and prevent recurrence.
- Ensure compliance with cGMP standards throughout the investigation process.
- Support ongoing change initiatives and process improvement activities within the organization.
Key Skills and Requirements:
- Degree in chemistry, biotechnology, life sciences, or a related field.
- Familiarity with deviation management and cGMP standards in a regulated pharmaceutical or API industry.
- Knowledge of biotech manufacturing processes and analytical methods is advantageous.
- Experience with Human and Organizational Performance and risk management approaches is beneficial.
- Fluency in English (written and spoken); German language skills are a plus.
- Strong technical writing, presentation, and communication skills.
- Structured, organized, and detail-oriented working style. Open-minded, agile, and motivated to drive results.
If you are having difficulty in applying or if you have any questions, please contact Josh Bye at j.bye@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists 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.
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