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Compliance Manager (f/m/d) 100% Emploi Plein temps

il y a 9 mois Training Basel
Détails de l'annonce

My main tasks will be...


  • Establish procedures to define processes within Quality or support other functions to define and document procedures according to their needs
  • Implement global procedures on a local level by assessing gaps, updating or issuing local SOPs
  • Responsible for maintaining all documentation effective and updated concerning site relevant processes
  • Effective implementation, review and updating of the site quality plan, contamination control strategy and site risk register
  • Responsible for the management of site relevant suppliers : introduction, lifecycle, overview and regular review
  • Supporting audits to suppliers (virtual /on-site) and follow up with reporting and CAPA plans
  • Participate/lead continuous improvement initiatives at the site
  • Representing the site to the global quality systems network and supports projects and initiatives on the local level
  • liaise with other areas/departments for cross functional topics to be addressed to ensure compliance and harmonisation
  • Conduct/support self-inspections and have the overview of the status for the site
  • Handle and maintain KPIs with regular reporting and drive improvement initiatives
  • Responsible for regulatory surveillance, including compendia as well as pharmaceutical legislation


I bring with me...


  • Bachelor, master’s degree in pharmacy, microbiology, biotechnology, life science or related field
  • Minimum 5 -8 years of experience in GMP environment , in quality or in operations (manufacturing, QA or in QC)
  • Excellent verbal, written and interpersonal communication skills
  • Fluent in English (written and spoken)
  • Knowledgeable in electronic QMS tools such as Trackwise is a plus
  • Good knowledge of MS Office Applications
  • Ability to prioritize and manage work to critical project timelines in a fast-paced environment
  • Independent, organised and goal-oriented personality
  • Solution oriented quality mindset


My reasons for choosing Bacthera...


  • Innovative and fast growing start-up company with short decision-making processes
  • Flexible working hours (possibility of Home Office)
  • Motivated, agile and multinational team
  • Very good pension fund and attractive salary
  • Fringe benefits (e.g. Lunch card, deduction at different stores, Job ticket for public transport)
  • Interesting and diversified tasks


My future working place will be...

Basel / Stücki Business Center

About Us

Bacthera is a leading contract development and manufacturing partner (CDMO) for biotech and pharma customers. We enable our customers to bring life-changing treatments to patients. We operate from our headquarters in Basel (CH) and have production facilities in Denmark and Switzerland. We bring together best-in-class, complementary capabilities and we are the first CDMO globally to provide a full supply chain that offers manufacturing of live bacteria strains for therapeutic use.