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QAV Specialist - Buffer

  1. Denmark
  1. Contract
Competitive
  1. Compliance / Quality Assurance
06-02-2024
32742
QAV Specialist - Buffer - Pharmaceuticals - 12-Months Contract 

Our client, a global CDMO in pharmaceutical manufacturing, is recruiting for a QAV Specialist to join them on their new expansion project. Based in a charming Nordic location, this on a contractual basis, and will involve significantly growing the sites capacity for the manufacture of Biologics.


The successful QAV Specialist will be responsible for:
  • Provide quality and cGMP input and oversight for all start-up project activities.
  • Provide QA support for risk-based verification activities in the capacity of Quality Assurance Subject Matter Expert. Review and approval clean utility documentation from design to post execution.
  • Participate in verification quality risk assessments and provide quality oversight to ensure verification quality risk assessments are effectively maintained/controlled.
  • Review and approval of engineering functional area documentation (SOP, Work Instructions, Criticality Assessments, technical report and protocols).
  • Complete on behalf of Quality Engineering Vendor assessments.
  • Authoring, review and approval of QA-related procedures.
  • Oversee the effective documentation and tracking of quality management system activities including deviations and change controls and CAPA.
  • Review and approve Validation protocols as required.
  • Support the vendor quality management programme.
  • Participate in regulatory inspections as required.
  • Develop and report quality metrics.
  • Represents Quality Assurance to guide various projects and technical meetings, as needed.
  • Responsible for documenting and reporting compliance issues to management.

The ideal candidate will possess:
  • Extensive QAV experience in a pharmaceutical manufacture/biopharmaceutical environment. (BDS experience is essential).
  • Must have strong process knowledge to include buffer prep/ buffer hold.
  • An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
  • Excellent communication & presentation skills are essential.
  • Excellent time management organisational skills along with a proven ability to multi-task.
  • Must have experience of working from initial project phases through to final hand over, engaging with Stakeholders/ User Groups/ Procurement/Suppliers.
  • This individual must have had experience of a similar project with a multi-million capital spend.
If this role is of interest to you, please apply now! 
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