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
Profile
- 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 and 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
- Ability to work with and lead a team of SMEs without formal authority, as well as to deliver projects working independently
Benefits
- A very renowned company
- You will work in an international environment
- Dynamic and innovative market environment
- Overtime compensation
About Hays
With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.
Staffing process for freelance specialists
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We carry out a detailed analysis of your technical qualifications on the basis of your CV, your application documents and your profile.
Contact at Hays
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