Main Responsibilities:
·Responsible to own, author 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.).
·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.
Qualifications and Experience:
·Relevant working/residency permit or Swiss/EU-Citizenship required
·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.
·Ability to work with and lead a team of SMEs without formal authority, as well as to deliver projects working independently.