SOP Coordinator (part time - 1 year assignment)

Lausanne, Vaud, Switzerland · Quality expand job description ↓

Description

Debiopharm Group™ is a Swiss-based global biopharmaceutical group of five companies active in the development and manufacture of drugs and diagnostics tools. Debiopharm focuses on developing prescription drugs that target unmet medical needs. The group in-licenses and develops promising drug candidates. The products are commercialized by pharmaceutical out-licensing partners to give access to the largest number of patients worldwide.

For our Quality team in the Research and Development department based in Lausanne we are looking for a:


SOP Coordinator (60% - 1 year assignment)

In this role, you will be responsible to coordinate SOP documentation system and training in Clinical Quality Management to ensure that clinical studies sponsored by Debiopharm International S.A. (DPI) and pharmacovigilance activities are conducted in compliance with international Good Clinical Practices (GCP) guidelines and applicable regulations.

Your main responsibilities:

  • To act as SOP coordinator in DPI documentation system;
  • To coordinate and support the operation of DPI SOP Committee in ensuring quality documents are managed as per relevant requirement;
  • To support the process of handling internal training related to GCP compliance;
  • To link SOPs with ENNOV training module and create where necessary new training modules;
  • To follow-up CAPA activities to ensure GCP inspection readiness;
  • To support the maintenance of clinical quality system for DPI in compliance with the laws and regulations governing the conduct of clinical trials (GCP);
  • To support internal review and audit process of trial master files as needed;
  • To support the process of handling relevant databases related to audit, inspection and SOP deviations;
  • To maintain Key Performance Indicator for the Quality Management department
  • To support administrative processes for the Quality Management department (budget follow-up, processing of travel expenses, invoice, contracts etc.)

Requirements

Your profile:

  • Documentation specialist (or equivalent)
  • Excellent knowledge in electronic documentation systems
  • Excellent knowledge in Microsoft Office Suite (Word, Excel, SharePoint…)
  • Good knowledge of GCP with a proven track record
  • 2-3 years of experience in Quality Management in GCP compliance area
  • Rigor, excellent coordination capabilities and attention to detail
  • Flexibility and adaptability, ability to multi-task
  • Capacity to keep an overall view while bringing enough attention to details
  • Fluent in English and French

Debiopharm can offer you:

  • An international and highly dynamic environment, with a long term vision
  • The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry
  • The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success.
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