Computer System Validation Expert
Posted 4 hours 23 minutes ago by CK Group
Permanent
Not Specified
Laboratory Jobs
Neuchâtel, Neuchâtel, Switzerland
Job Description
CK QLS are recruiting for a Computerized System Validation Specialist to join our client on a contract basis at their site in Neuchatel.
START DATE: ASAP/October 14th 2024
DURATION: 12 months
Duties:
The job holder is accountable for life cycle management activities of systems used in the QC Laboratories of Neuchâtel Switzerland with a focus on:
Analytical Instrument Qualification
Computerized System Validation
In addition, the job holder also supports the Data Integrity deployment in the department following cGMP, policies and EHS requirements.
Validation and Qualification Activities:
Author specification documents (URS-FS-SDCS).
Author plans, protocols, and reports
Execute and document Equipment & Software validation.
Oversee validation and qualification activities executed by analysts, provide training and support.
Assure cGMP compliant and timely implementation and maintenance of validated status of systems.
Conduct/participate in risk assessments, root cause analysis and investigations.
Identify, lead and drive improvements or change.
Provide technical assessments on protocols deviations and investigations.
Serve as SME for internal technical group discussions.
Quality Control Support Activities:
Support and interface with process owners of systems.
Participate to daily activities upon request (provide technical and statistical support)
Experience:
Master s in engineering, Computer Science, or related technical field
Minimum of 5 years of relevant validation experience in the biotechnology or pharmaceutical industry
Extensive experience with validation life cycle requirements for cGMPs laboratory systems
Experience with project management and/or leadership enabling cross functional engagement to deliver project goals and timelines.
A thorough knowledge of DI requirements and standard regulations for cGMPs operations
Provide input on project execution and act as a consultant to management.
Author and review protocol and reports as per established company guidelines and SOPs.
Identifying and communicating risks in area of responsibility and across the site.
If you are interested or would like to apply for this role please reach out to Rob Angrave at CK QLS on or email
All applicants must be entitled to work in Switzerland and have full rights to work.
START DATE: ASAP/October 14th 2024
DURATION: 12 months
Duties:
The job holder is accountable for life cycle management activities of systems used in the QC Laboratories of Neuchâtel Switzerland with a focus on:
Analytical Instrument Qualification
Computerized System Validation
In addition, the job holder also supports the Data Integrity deployment in the department following cGMP, policies and EHS requirements.
Validation and Qualification Activities:
Author specification documents (URS-FS-SDCS).
Author plans, protocols, and reports
Execute and document Equipment & Software validation.
Oversee validation and qualification activities executed by analysts, provide training and support.
Assure cGMP compliant and timely implementation and maintenance of validated status of systems.
Conduct/participate in risk assessments, root cause analysis and investigations.
Identify, lead and drive improvements or change.
Provide technical assessments on protocols deviations and investigations.
Serve as SME for internal technical group discussions.
Quality Control Support Activities:
Support and interface with process owners of systems.
Participate to daily activities upon request (provide technical and statistical support)
Experience:
Master s in engineering, Computer Science, or related technical field
Minimum of 5 years of relevant validation experience in the biotechnology or pharmaceutical industry
Extensive experience with validation life cycle requirements for cGMPs laboratory systems
Experience with project management and/or leadership enabling cross functional engagement to deliver project goals and timelines.
A thorough knowledge of DI requirements and standard regulations for cGMPs operations
Provide input on project execution and act as a consultant to management.
Author and review protocol and reports as per established company guidelines and SOPs.
Identifying and communicating risks in area of responsibility and across the site.
If you are interested or would like to apply for this role please reach out to Rob Angrave at CK QLS on or email
All applicants must be entitled to work in Switzerland and have full rights to work.