Required Skills
bachelor’s 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-organized 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
Job Summary
The Deviation Manager will be part of a team established to own and investigate deviations at a large scale mammalian cell culture facility. They 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.
Experience
Previous experience in Deviations and cGMP in a regulated pharmaceutical/API industry
Contract Information
12+ Months, extendable
Job 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.
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