Quality Control Qualification & Validation Specialist

Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce

Currently we are looking for a Quality Control Qualification and Validation Specialist for 1 year to start ASAP.

Janssen Vaccines in Bern (Switzerland) belongs to the Janssen Pharmaceutical Companies of Johnson & Johnson. Janssen is an organization of over 30,000 professionals working passionately to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. In Bern, about 300 people of over 20 nationalities work together with the wider Janssen organization and partners on the development, manufacturing and analytical testing of novel vaccines and bacteria-based pharmaceutical products. We are committed to bringing meaningful innovation to global health by combating major threats to the health of people worldwide.

Main Responsibilities:
- Support the qualification and validation activities of computerized and non-computerized systems within the Quality Control department
- Perform and/or support the writing of specification documents (URS) & system impact assessments (SIA)
- Support the calibration & maintenance of laboratory equipment
- Review test protocols, plans and reports
- Support test execution
- Supporting the timely and effective completion of investigations, change controls and CAPA's

Qualifications:
- Degree in a LifeSciences/ Biotechnology, Chemistry discipline or comparable work experience
- Experience with the use and qualification of laboratory and analytical QC equipment
- Experience in the qualification of non-computerized equipment (TCUs, Scales etc.)
- 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

If you are interested in hearing more about our Quality Control Qualification and Validation Specialist role, please do not hesitate to apply through the provided link today and a member of our recruitment team will be in touch!