CSV Specialist
- Eastern Europe
- Contract
- Life Sciences
Our client, One of the world’s largest pharmaceutical organisations is responsible for developing and manufacturing medicines and vaccines for a wide range of medical disciplines. They have been responsible for the development of many blockbuster drugs in both the USA and the EU and have a presence in the USA, EU and Asia-Pacific.
With continued organisational growth and a considerable amount of investment across the portfolio and capital programme they are seeking the expertise of CSV Specialist.
CSV Specialist Responsibilities:
- Assessing Automation changes (ACRs) for impact to project verification documentation (commissioning test protocols and verification test protocols).
- Writing and executing ATPs based on existing client templates and project URS requirements.
- Coordinating with vendors to ensure that Software Applications are properly configured.
- Using AgileDoc to generate FDSs and DDSs.
- Using InfoBatch to create batch reports (using client provided templates). Some modifications to templates may be needed.
- Redlining hand-generated FDSs/DDSs, as needed by Automation team members.
- An Automation Engineer, proficient in configuring DeltaV, with 5+ years of computer system validation/verification experience on pharmaceutical projects of similar size.
- Must have knowledge of GAMP 5 and must be able to ensure that all project computer system verification is compliant with GAMP 5.
- Strong preference will be given to resources local to the Central European region.
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.
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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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