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QAV Specialist - Fill Finish

  1. Denmark
Denmark
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation, Compliance / Quality Assurance
19-01-2021
25645/JS

This vacancy has now expired

QAV Specialist – Fill Finish – Denmark – 12 month contract

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 Engineering Manager, this individual will be responsible for the delivery of the QAV/Quality Engineering activities on a complex Fill Finish 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. (Fill Finish 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.


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

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