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API Compliance Head - Responsible Person (f/m/d) 100%

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Offered by:

IMCD Switzerland AG

Medical
Basel

Your tasks and responsibilities:

  • Perform and monitor GDP Quality tasks and Health Authorities publications to guarantee the company is working in compliance with the regulations related to the activities as pharma API distributor
  • Support the business unit International API in the implementation of its strategic goals
  • Lead and supervise the API Compliance department with two direct reports
  • Maintain the GDP Quality Management System (QMS) and perform Review Reports
  • Manage documents and records of the GDP Quality System as per ALCOA requirements
  • Create, execute and follow-up GDP Annual Training Program fulfilment and promote Quality Risk Management
  • Create and execute the Internal and External audits annual plan and participate in Inspections and Customer audits
  • Be the contact person to contracted-qualified logistic partners (for GDP topics)
  • Manage the Change Control for changes promoted by IMCD Switzerland AG
  • Ensure the Change Control process is organized for changes raised by manufacturers of APIs
  • Manage Deviations, Complaints, Returns and CAPAs
  • Check CoA of narcotics, bulk drugs and contract manufactured goods for IMCD Switzerland AG
  • Perform final evaluation of qualification of new customers, products and suppliers
  • Lead Q-Agreements for contracts promoted by IMCD Switzerland AG and conduct final approval (second reading) of Q-Agreements promoted by customers
  • Approve Compliance documents (e.g. SOP, ERP manuals, Q-Agreements)

 Your competencies and qualities:

  • Education in the areas of Chemistry, Pharmacy, Veterinary, Biology or Food science
  • Place of living and place of work (Basel) must not be more than a 2-hours’ drive apart (required), willingness to frequently travel to the Zurich office
  • Several years of professional experience in quality assurance (QA) in the pharmaceutical or chemical sector (preferably GMP or GDP)
  • Analytical thinking to manage in advance new legal requirements
  • Strong organizational, negotiation and project management skills
  • od kledge of MS Office tools and ERP tools
  • Fluent in English and German languages, spoken and written
  • Kledge of Swiss legislation and regulations relating to medicinal products (preferably)
  • Communicative, convincing and open personality with an independent, structured and quality-conscious way of working

 What we offer:

  • A challenging task in a dynamic and innovative environment
  • The opportunity to promote your own ideas in a competent and collegial team and to actively shape the further development of IMCD Switzerland and beyond
  • A wide range of training opportunities and a corporate culture that promotes performance
  • Modern and attractive workplace at our locations with the possibility of WorkSmart, our hybrid working model 3:2
  • Competitive salary including additional benefits

Are you interested? If so, we would like to get to k you!In case you have any questions about this position, please contact Evelyn Stirnimann.IMCD Switzerland AG – Human Resources – Hufgasse 10 – 8008 Zürich - www.imcdgroup.com