Quality and Validation Specialist (5571)

Quality and Validation Specialist – 5571

Our client is a specialist biotherapeutics manufacturer with over a century of experience treating various diseases worldwide. They are committed to patients with coagulation disorders, immunological diseases, enzyme deficiency diseases and other rare diseases.

We are currently sourcing a Quality and Validation specialist for our client in Bern area. This is a 6-month contract role, with chances of extension. An ideal candidate is someone who has at least 3 months of experience.

Main Responsibilities:

·       Execution of validation projects according to company standards:

·       Preparation of risk analyses and assessments

·       Planning and execution of field studies

·       Planning and execution of process and cleaning validations

·       Evaluation of validation data

·       Preparation of process and cleaning validation reports

Qualifications and Experience:

Relevant working/residency permit or Swiss/EU-Citizenship required.

·       Scientific Degree (e.g. bachelor's, master's, doctorate in pharmacy, pharmaceutical technology, biology, chemistry) or comparable training;

·       several years of industry experience and/or 3+ years of experience in validation with demonstrated suitability for this role may also be considered

·       GMP experience (preferred)

·       Experience with current industry guidance, best practices and regulatory requirements for the process and/or cleaning validation (preferably)

·       Good knowledge of German (native language) and English (B2/C1) both spoken and written

·       Flair for writing documents, Interest in technical processes, Working independently, Ability to work in a team, Working precisely, Rules compliance

·       Flexibility, Quick familiarization with new subject areas, Ability to work under (time) pressure,