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Lab Systems Validation Expert
Eingestellt von Quanta Consultancy Services
Gesuchte Skills: Client, Network, Support
Projektbeschreibung
START DATE: January 2018
Duration: 4 months (with possible extention)
Location: Belgium
Our global biotechnology client is looking for a Lab Systems Validation Expert to support the team in a site wide software rollout project.
You and the team will be responsible for the successful implementation of the new lab software (Nova Flex 2) on site.
Some main duties include:
-Solve problems during validation process and address/advise on issues such as deficiencies, deviations and change control.
-Ensure compliance with computerised systems to relevant regulatory requirements (eg cGMP/GLP/GAMP/GALP).
-Review existing SOPs and prepare drafts for future lab software validation projects.
-Draft templates for High level Risk Assessments, User Requirements Specification, Validation Plan and Validation Summary Reports.
-Prepare validation documentation packages and complete validation of Computerized Laboratory Systems.
-Provide QC Equipment Validation: small-scale lab equipment (filters, incubators etc)
-Improve and upgrade the network filing system.
-Ensure accuracy and timeliness of software compliance for 2018.
REQUIREMENTS:
-The successful candidate will have experience in Cgmp/QC Lab Instruments validation.
-Strong knowledge of validation of QC Lab Instruments and cGMP requirements.
If this exciting project with a global biotech company is of interest, apply now.
Duration: 4 months (with possible extention)
Location: Belgium
Our global biotechnology client is looking for a Lab Systems Validation Expert to support the team in a site wide software rollout project.
You and the team will be responsible for the successful implementation of the new lab software (Nova Flex 2) on site.
Some main duties include:
-Solve problems during validation process and address/advise on issues such as deficiencies, deviations and change control.
-Ensure compliance with computerised systems to relevant regulatory requirements (eg cGMP/GLP/GAMP/GALP).
-Review existing SOPs and prepare drafts for future lab software validation projects.
-Draft templates for High level Risk Assessments, User Requirements Specification, Validation Plan and Validation Summary Reports.
-Prepare validation documentation packages and complete validation of Computerized Laboratory Systems.
-Provide QC Equipment Validation: small-scale lab equipment (filters, incubators etc)
-Improve and upgrade the network filing system.
-Ensure accuracy and timeliness of software compliance for 2018.
REQUIREMENTS:
-The successful candidate will have experience in Cgmp/QC Lab Instruments validation.
-Strong knowledge of validation of QC Lab Instruments and cGMP requirements.
If this exciting project with a global biotech company is of interest, apply now.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Sonstiges