Cqv / Csv Consultant

vor 3 Monaten

Bern, Schweiz Consultys Vollzeit

As part of our development, we are recruiting a CQV/CSV Consultant to join our teams.
- Assess laboratory instruments and software for their compliance with Data Integrity guidelines.
- Implement Data Audit Trail Reviews for laboratory instruments and software in accordance with client guidelines.
- Manage local and global qualification and validation projects.
- Collaborate with internal and external stakeholders within qualification and validation projects for technical requirement specifications, data integrity, and automation activities.
- Support the update of procedures related to laboratory instrumentation and computerized systems (i.e., USP, 21CFR Part 11, Annex 11 regulations) to ensure compliance with guidelines and industry best practices, as well as harmonization within the global organization.
- Collaborate with relevant stakeholders to ensure laboratory are complient with Data Integrity guidelines by implementing a Data Audit Trail Review process.

Requirements:

- University degree in a relevant scientific discipline (Biology, Microbiology, Chemistry, Bioinformatics, Computer Science, etc.).
- 3+ years’ experience in a pharmaceutical/medicinal GMP testing environment using a variety of testing instrumentation, with experience in equipment qualification or CSV and lifecycle activities.
- First project management experience in an operational environment.
- Knowledge of regulations on computerized systems and laboratory automation, and a willingness to extend skills and know-how in the field.
- Strong written and verbal communication skills in German and English, both oral and written, to ensure effective collaboration with cross-functional teams both locally and globally.

proactive and self-responsible approach
- Strong analytical/problem-solving skills, technical IT affinity, and organizational skills.
- Ability to work independently and as a team member in a high-performance environment.

Qui sommes nous ?

For more than 19 years, through our consulting and engineering activities, we have supported our clients throughout the entire lifecycle of biotechnology, pharmaceutical and device products.

Part of an organization of more than 750 Life-science experts, Consultys Switzerland supports and develops talented individuals recognized for their technical and scientific expertise. Our activities allow us to be present in both French-speaking and German speaking Switzerland, with agencies in Lausanne and Basel.

At Consultys, we're proving that it's possible to combine people and performance.

Much more than concepts, our 3 values "Respect, Recognition and Transparency" guide us and are the foundation of our history, the heart of our group's success.

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