Computer Systems Validation Specialist
- Brussels
- Contract
- Commissioning, Qualification and Validation
This vacancy has now expired
Our client, one of the worlds largest pharmaceutical organisations is responsible for developing and manufacturing medicines, consumer products and vaccines for a wide range of medical disciplines. They have been responsible for the development of several key and revolutionary products 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 currently seeking the expertise of CSV Specialist with extensive experience automated systems experience to join their team.
Essential Duties and Responsibilities for this role include, but are not limited to, the following:
- Writing, reviewing, and approving of validation plans and validation summary reports
- Reviewing and approving of Technical Change Description
- Reviewing and approving of IQOQ protocols & reports, PQ protocols & reports
- Reviewing of CVS specific SOP’S and Templates
- Ensure the proper execution of the qualification and validation activities with respect of the internal validation methodology
- University (Master) degree in Sciences / Biological Engineering (e.g. Pharmacist / Master in Sciences / Bio Engineer)
- Certification in computer system validation or equivalent is a plus.
- Fluent in French and English is advantageous
- Extensive experience in a computer systems validation role working on automated systems such as PLC, HMI, SCADA, DeltaV, Archestra.
- CGMP and specific regulations and guidelines applicable to computerized and automated systems (GAMP, Eudralex Vol 4 annex 11, 21 CFR part 11)
- Validation practices and guidelines (life cycle approach, ICH, ASTM E2500)
If you are interested in this role, please apply now for more information!
The candidate must have the rights to work in the location stated in the job advert.
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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
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
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
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