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QAV Engineer

  1. Denmark
  1. Contract
25644 JL
  1. Compliance / Quality Assurance
Date Posted27 Oct 2020

This vacancy has now expired

QAV Engineer - Contract - Denmark

A global Biopharmaceutical company require QAV Specialists to manage the Quality Engineering activities on a substantial biotechnology capital investment project (CAPEX) at one of their campuses, based in Denmark. 

Reporting into the Quality EngineeringManager, this individual will be responsible for the delivery of the QAV/Quality Engineering activities on a complex Drug Substance manufacturing expansion project. Once complete, this facility will house large scale commercial manufacturing capability.

Key Responsibilities
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 equipment/utilities verification 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). URS’s will be key initially.
  • 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.

Key Requirements
  • Extensive QA experience in a pharmaceutical manufacture/biopharmaceutical environment. (Bulk drug substance experience is essential).
  • Must have strong process knowledge to include upstream and/or downstream processing.
  • 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 organizational 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.

For more information on this position, please apply with a copy of your up to date CV today! 

The candidate must have the rights to work in the location stated in the job advert.

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