Computer System Validation Lead
- Vienna
- Contract
- Commissioning, Qualification and Validation
This vacancy has now expired
The CSV Lead will play a key role in the successful delivery of this 220 million expansion and fit-out project. The project is currently in the design phase, so it is a fantastic opportunity for someone who is looking for early involvement in creation of a site and setting up the IT part of the business for successful delivery of products to support a growing franchise.
Overview of Requirements / Job Specification:
- Someone with great familiarity with Automation Qualification, GMP requirements, SDLC
- Review and approval of Supplier provided test documentation for regulatory control as well as S88 Batch documentation deliverables
- Support for management of Software FAT execution
- Review and guidance of Qualification documentation for packaged automation equipment (e.g. Centrifuges, Utility packages)
- Development of high level automation SDLC deliverables such as Quality Assurance Plans and Quality Assurance Summary Reports
- Regular communication with site quality representatives to plan automation qualification strategy and deliverables
- Support for multiple automation projects
- Automation IQ/OQ/PQ support
- German Speaking
- Familiarity with Siemens PCS7 DCS and Siemens S7 PLCs and Siemens HMIs.
- Familiarity with IT Shop floor infrastructure
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We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
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Alex
I manage this role.