Deviation Manager (m/f/d)

Deviation Manager

m/f/d, Wallis

The Deviation Manager will be part of a team that is currently established to own and investigate deviations at a large scale mammalian cell culture facility.
He/She represents the Operations Unit, taking ownership of Deviations which arise; to investigate the root cause(s), the impact/potential impact on product and/or systems, and to define appropriate CAPA(s) as solutions.
Responsibilities:

• 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.).
• 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
• 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.

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