Qualification Expert (m/f/d)
Responsibilities
- Responsible for planning and conducting qualification and validation activities
- Creating and reviewing qualification and validation documents (DQ, IQ, OQ, PQ)
- Carrying out and documenting qualification processes for our Embedded Systems / process automation systems according to cGMP
- Developing, implementing, and conducting test strategies, test plans, and test cases to verify system performance and compliance
- Providing expertise in creating specifications (e.g., URS)
- Working with IT, process engineering / automation, quality assurance, and production departments to ensure smooth integration and qualification of the systems
- Handling qualification impact assessments as part of change or deviation process management
- Collaborating closely and communicating intensively with other departments
- Providing assistance in the processing of deviations, changes and CAPAs
Profile
- Technical degree in a relevant field
- Further training and hands-on experience in the area of GMP
- Solid experience in the qualification and validation of machines and processes, preferably in the pharmaceutical industry
- Hands on work experience in qualification
- Experience with Siemens COMOS, eVAL (ValGenesis) and Veeva
- Fluency in German spoken and written needed, English fluency written and reading comprehension
- Independent and structured way of working with a self-reflecting behaviour and to continuously improve the processes
- High degree of initiative, flexibility and quick comprehension skills
- Enthusiasm for working together in self-organized teams and for your own areas of responsibility areas of responsibility with a focus on the big picture
Benefits
- Unlimited project contract possible
- Fascinating, innovative environment in an international atmosphere
About Hays
Our many years of recruitment experience and our expert knowledge of the engineering job market make us a strong partner for engineers and technicians. We maintain close relationships with customers across all industries and therefore can provide engineering specialists with exciting projects and attractive job opportunities, drawing on your personal interests and experience. As your professional companion, we support you throughout the entire process, from the first contact to the first day on your new job – all this completely free of charge. Register now and look forward to many interesting and suitable positions and projects.
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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