Are you passionate about technology and like to take on complex technical challenges? Do you want to work in exciting projects at renowned clients? At ALTEN we believe that knowing and meeting the expectations of our consultants is a key factor in our success. Our consultants make the difference. Do you want to make the difference too?
- Coordination of computerized system qualification and validation activities within the Quality Control department
- Define the validation strategy
- Perform and/or support the writing of specification documents (URS)
- Review test protocols, plans and reports
- Support test execution
- Support and train team members in CSV methodology
- Supporting the timely and effective completion of investigations, change controls and CAPA’s
- Degree in a Life Sciences/ Biotechnology, Chemistry discipline or comparable work experience
- Several years of experience in computerized system validation (CSV) in a GMP environment and good knowledge of related regulatory requirements in the life sciences industry (GAMP 5, 21 CFR part 11, ...)
- Good understanding of analytical technologies,
- Strong analytical thinking and problem-solving ability
- Excellent communication and teamwork skills
- Ability to simultaneously support multiple projects, duties and assignments and prioritize accordingly
- Excellent writing skills for scientifically sound technical documents, instructions, protocols and reports.
- Self-dependent way of working and taking ownership of assigned task to plan and deliver according to agreed timelines.
- Good verbal and written skills in English, German is a plus
We are looking forward to getting to know you and your ambitions!