Deviation Specialist
Vor 3 Tagen
The Team at Lonza is searching for a talented Deviation Manager to join their Bioconjugates Operations team.
This role will be responsible for owning and investigating deviations at our Bioconjugates facilities in MC1 and PCP. The ideal candidate 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, investigate, author, and record assigned 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 investigation tools are used to systematically define all root causes and contributing factors.
- Define and agree with SMEs appropriate CAPA(s), and associated Effectiveness Checks.
- Ensure cGMP compliance and consistency through the investigation process and drive their quality records to completion and closure according to scheduled release times.
- 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 or bioconjugation manufacturing processes and analytical methods is an advantage.
- Experience with Human and Organizational Performance & risk management approaches is an advantage.
- Fluency in English, 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-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive.
- Ability to work with and lead a team of SMEs without formal authority as well as to deliver full projects working independently.
Lonza is a global leader in life sciences with operations across three continents. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people.
At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
Join us in making a meaningful difference in the lives of millions of people around the world.
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