The Deviation Manager (m/f/d) will be part of a team that is currently established to own and investigate deviations at a large scale mammalian cell culture facility.
You will represent 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.
Key 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.?
Key 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.
- Ability to work with and lead a team of SMEs without formal authority, as well as to deliver projects working independently.
Interested? Send your CV to Daria at d.finikova@panda-int.com or call +41445514407.