CSV Consultant
- Norway
- Contract
- Commissioning, Qualification and Validation
This vacancy has now expired
Our client specialises in providing lifesaving medicines and technologies and their site in Norway manufactures products that are used globally in over 50 different countries.
The client is currently looking to add the skills of a CSV Data Integrity Consultant to their team to support ongoing activities and planned activities. The successful candidate will provide support and perform activities related to data integrity (DI) and computer system validation (CSV).
Essential Duties and Responsibilities for this role include, but are not limited to, the following:
• Alarm management for production GxP system –
o Define GxP relevant alarms
o Define GxP critical alarms
o Define action upon GxP critical alarms
o Update SOP with action
• Computer system validation (QC and Production systems)
o Support validation of; Density, pH and conductivity meter
o Prepare Protocols; URS -> DQ -> IQOQPQ
o Perform validation and qualification testing
• Configuration of SCADA system (user management and security)
o Identify system that may be interfaced with SCADA system
o Interface HMI/PLC with SCADA
o Setup user management and permissions
o Configure security policy
• Provide CSV expertise and training to local resources
• Process mapping with respect to DI compliance
Desirable Experience:
The candidate need to have experience in several of these field:
• Extensive CSV work on Manufacturing Automated and Computerised System (e.g. SCADA, Siemens HMI)
• Previous experience with CSV work on laboratory equipment
• GAMP5 knowledge
• Previous Data Integrity experience
• A strong understand of 21 CFR part 11
• Annex 11
• USP 1058
• GxP regulations
• Abel guide site personnel in CSV topics
• Risk Assessments
If this sounds like the position for you then please apply 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.
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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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