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Audit Readiness Coordinator

  1. Denmark
Copenhagen
  1. Contract
Competitive
  1. Compliance / Quality Assurance
37076
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Audit Readiness Coordinator - Denmark, Copenhagen - 12 Month Contract

Our client, a global CDMO in pharmaceutical manufacturing, is recruiting for a Audit Readiness Coordinator to join their new and exciting large-scale CAPEX investment programme. With a mission to provide process development and cGMP production in cell culture, microbial fermentation, and gene therapies, this is an outstanding opportunity make a genuine contribution to the biopharmaceutical industry.

Responsibilities include:
  • Provide oversight and plan for all relevant audit tasks and topics.
  • Provide overview of supplier and owners of each audit tasks and topics.
  • Prepare templates used to prepare and present at audit.
  • Coordinate with stakeholders for audit/inspection that deadlines and tasks are met
  • Ensuring alignment with the PQS department on quality and form
  • Coordinate with PQS department, regarding resources for audit and inspection and regarding communication.
  • Track progress of audit readiness and report to operational readiness
  • Assist QA Project Director and Audit Readiness Lead on monitoring compliance in projects.
Key requirements include:
  • Extensive Project QA experience in a pharmaceutical manufacture/biopharmaceutical environment.
  • Knowledge of and experience running audits and inspections, setup and tasks.
  • Knowledge of EU GMP Vol 4 and how this applies to projects.
  • Knowledge of how to report to management at various levels/ stakeholders.
If this role is of interest, please apply now!
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