Lead the investigations that strengthen compliance and keep manufacturing on track.
Proclinical is hiring a Deviation Investigator Manager to oversee and execute deviation investigations in a high‑volume manufacturing environment. The ideal candidate will apply structured problem‑solving methodologies to determine root causes, assess operational impacts, and implement CAPAs that strengthen overall quality and compliance.
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, Defense Analysis, Event Causal Factors Chart, and Fishbone Diagrams to systematically determine root causes and contributing factors.
* Define appropriate CAPAs and effectiveness checks to address deviations and prevent recurrence.
* Ensure compliance with cGMP standards throughout the investigation process and drive timely closure of quality records.
* Support ongoing change initiatives and process improvement activities within the organization.
Key Skills and Requirements
* Bachelor's degree in chemistry, biotechnology, life sciences, or a related field.
* Familiarity with deviation management and cGMP practices in a regulated pharmaceutical or API industry is highly advantageous.
* Knowledge of biotech manufacturing processes and analytical methods is beneficial.
* Experience with Human and Organizational Performance and risk management approaches is an advantage.
* Fluency in English (written and spoken); German language skills are a plus.
* Strong technical writing, presentation, and communication skills.
* A structured, organized, and focused working style, coupled with an open-minded and agile approach to new ideas.
If you are having difficulty in applying or if you have any questions, please contact Emile De Beer at e.debeer@proclinical.com.
Apply Now
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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