Tasks :

• Responsible to own, author, record and investigate Deviations.

• Liaise with Subject Matter Experts (SMEs) and key stakeholders to establish the root cause(s) of deviations and the potential impact of said deviations.

• Ensure proper investigational tools are used to systematically define the root cause(s) and contributing factor(s) (e.g., Fault Tree Analysis, Defense Analysis, Event & Causal Factors Chart, Fishbone Diagram, etc.).

• Contribute to define appropriate CAPA(s), and associated Effectiveness Checks, as solutions to correct deviations and prevent future recurrence.

• Ensure cGMP compliance through the investigation process, and to drive their quality records to completion and timely closure.

• Support the business through ongoing change and process improvement activities.

Qualification:

• Bachelor degree in chemistry, biotechnology, life science or related field.

• Previous experience in Deviations and cGMP in a regulated pharmaceutical/API industry is a strong advantage.

• Knowledge of biotech. manufacturing processes and analytical methods is an advantage.

• Experience with Human and Organizational Performance & risk management approaches is an advantage

• Fluency in English, both written and spoken. German is an advantage.

• Technical writing & presentation/communication skills are key for the role. Demonstrated previous experience is a strong advantage.

• Structured, focused and well-organised working attitude. Open-minded for new ideas and suggestions; agile, highly motivated and dynamically driven.

Requirements:

Start : 02.03.2026