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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.
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.
- 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.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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
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