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Associate, Artwork and Compliance

The Role

The Compliance and Artwork Associate will work in the CMC Commercial Supply Chain team. You will support the commercial supply chain in CMC in Coordinating Compliance activities and managing routines for Artwork Management with key stakeholders in QA, RA, and external partners.

Besides the operational day-to-day activities within Artwork management and compliance coordination, the role will support building up a GxP compliant commercial supply chain function in terms of systems, processes, and reporting structures.

The position reports to the Senior Director, Commercial Supply Chain.
 

Responsibilities

  • Manage process for artwork preparation, review, and approvals

  • Ensure Artwork is prepared according to current rules, procedures, and schedules. Coordinate these activities with internal stakeholders in QA, RA, and external partners (CMO’s and Artwork Provider)

  • Manage creation of Change Request for handling artwork changes. Follow up on open changes in order to ensure timely closure and proper house keeping and compliance to internal procedures

  • Support Commercial Supply Chain team in documenting procedures, update existing procedures, and work instructions

  • Handling of Deviations, CAPA’s and CR’s including following up on actions and acting as driver when relevant

  • Follow-up on timelines for department specific compliance tasks overall

  • Support preparation of audits and inspections and follow up on actions previous audits

  • Work with Quality Assurance in order to maintain GxP compliance throughout the supply chain network including exceptions handling – Investigate exceptions, determine root causes, implement CAPAs and drive closure

Requirements

  • Minimum Bachelor’s degree from a relevant education either technical university or business school

  • You have knowledge of GMP guidelines and hands-on experience in applying it to an operational environment

  • You have demonstrated your ability to manage and coordinate tasks across professions

  • It is an advantage if you have experience with Veeva Vault, artwork management systems, and SAP

Moreover, you meet the following:

  • Ability to be proactive, enthusiastic, and goal orientated

  • A team player with demonstrated ability to collaborate with a diverse group of internal and external stakeholders

  • Strong communication skills in English - both oral and written

Degrees of interest: Bachelor’s degree from a relevant education either technical university

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