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Compliance Specialist

 

Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a Compliance Specialist for a 12 x month contract, based in Basel, Switzerland.

Main Responsibilities:

  • Participating in or lead agreed Quality/Compliance projects, aligned with the company strategy and group objectives e.g. Quality/Compliance Task Forces, remediation projects
  • Actively manage assigned global quality activities emanating from Supply Chain initiatives and projects such as materials management, manage assigned activities related to Good distribution practices, warehousing
  • Responsible for implementing and sustaining site activities related to Vendor Supply Chain Integrity process
  • Defining and implementing the process for Global Supplier Complaints in accordance with principles outlined in “Systems and Tools”
  • Managing supplier lifecycle, onboarding, monitoring and decommissioning
  • Interfacing with major Supplier for which a business partnership has been assigned
  • Managing global Change control process regarding supplier management (internal and external suppliers), linked to materials management and supplier changes impacting Lonza globally
  • Creating, distributing and tracking regulatory/compliance gap Analysis observations at the sites. Collaborating with Quality compliance teams is essential to ensure Gap Analysis observations and content is fostering increased compliance
  • Responsible for the Regulatory intelligence process and tool (Redica systems)
  • Managing global Quality Risk Management
  • Providing content for the communication platform of the Global Quality Compliance and Supply Chain Group for assigned projects

 Qualifications and Experience:

  • Relevant working/residency permit or Swiss/EU-Citizenship required
  • 3 – 5 years in a similar role within Pharma
  • Fluent in English
  • Extensive knowledge of systems and tools, specifically Redica

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