QAV Specialist - Fill finish - Biopharm

QAV Specialist - Fill Finish -  Biopharm
 
Exciting new project based in Denmark have a contract requirement for an experenced QAV Specialist.
As part of a €900 million expansion project, you will be required to work on the €100 million new fill finish production line. 

Fill finish line: Featuring a fully-automated, cutting-edge system capable of producing up to approximately 35 million units per annum to cater to large-scale production. 

Reporting to the Quality Maanger you will be responsible for the delivery of the QAV Engineering activities on a complex Fill Finish manufacturing expansion project.

The requirement will be for initially 12 months with the view to extend beyond that point.

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 equipment/utilities verification documentation from design to post execution.  URS’s will be key initially.
• 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).
• 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 QA experience in a pharmaceutical manufacture/biopharmaceutical environment. (Fill Finish/Drug Product experience is essential).
• Must have strong process knowledge to include Drug Product/Fill Finish processing.
• An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
• Single use technology & ASTM E2500 experience highly advantageous
• 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.

If this role is of interest to you then please apply!

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

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