Deviation Manager
Key information
- Job ad expired
- Workload:95%
- Contract type:Temporary
- Language:English (Fluent)
- Place of work:Visp
We are looking for a Deviation Manager to join an established team investigating deviations at a large-scale mammalian cell culture facility.
Job description:
- 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.
Requirements:
- 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
- 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.
- Fluency in English, both written and spoken. German is an advantage.
