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Validation Specialist
Eingestellt von Harvey Nash IT Recruitment Switzerland
Gesuchte Skills: Support
Projektbeschreibung
Harvey Nash is looking for a Validation Specialist for a 7 month project in Switzerland.
The role is for a qualified person who will support the software quality assurance and validation activities for the Global Submissions Lifecycle (GSL) solution. He/she will work with cross-functional teams including business analysis, development, business and corporate quality teams to deliver business critical solutions.
You are responsible for:
- Assisting in the development, planning, directing and tracking of the validation of the GSL computer system
- Maintaining production computer systems in a validated state, monitoring all modifications or changes to systems or processes, initiating change control/revalidation as required and ensuring a continual state of inspection readiness with regard to GxP
- Working with project teams to come up with validation strategies for projects and working closely with project managers to meet the timelines
- Developing and writing validation project plans, master validation protocols, traceability matrices and summary reports by providing instructions and scientific rationale for the performance of validation studies
- Leading fellow technical and analysis team members in ensuring compliance with corporate quality standards and requirements
- Facilitating the translation of new and revised corporate quality requirements into practical application for revising, updating and adding new documentation to an existing computer system validation package
- Coordinating the testing efforts of the IT and business teams with regards to requirements, resource planning, test coverage, test strategies
- Advising the business SMEs and IT Applications staff to create thorough, accurate and comprehensive test scripts
- Developing and maintaining test metrics and generate reports for management use in determining project and applications test status
- Coordinating and interacting with all affected personnel in the execution of test scripts and validation protocols and gathering of test data and ensuring all protocol executions are documented and recorded in accordance with company quality policies, quality standards and SOPs
- Analyzing data to determine if it meets protocol acceptance criteria and document deviations as necessary and Ensuring all final reports are documented and approved
- Maintaining accountability for completion of required training for the position
Requirements:
- Minimum of 3 years of experience in validation and software testing in Pharmaceutical or Bio-Tech industry is required (regulated by government agencies, ie FDA, EMEA, Japan Health Authorities, Canadian Health Authorities, etc.)
- Experience in pharmaceutical regulatory is mandatory
- Track record in validating global solutions interfacing with other systems and involving multinational teams that are geographically distributed is mandatory
- Participation in at least one full life cycle implementation and production support is required
- Good understanding of FDA and GxP regulations pertaining to computer systems validation (CFR Part 11) and GxP is required
- Exceptional interpersonal, writing and communication skills and dedication to customer service and satisfaction are essential
- Experience participating in external regulatory audit/inspection teams is preferred
- Travel: up to 20-30% of the time, possibly overseas
- Working language: English
Are you available immediately, have experience working within a Life Science company? Please send your complete CV (Word documents preferred)
The role is for a qualified person who will support the software quality assurance and validation activities for the Global Submissions Lifecycle (GSL) solution. He/she will work with cross-functional teams including business analysis, development, business and corporate quality teams to deliver business critical solutions.
You are responsible for:
- Assisting in the development, planning, directing and tracking of the validation of the GSL computer system
- Maintaining production computer systems in a validated state, monitoring all modifications or changes to systems or processes, initiating change control/revalidation as required and ensuring a continual state of inspection readiness with regard to GxP
- Working with project teams to come up with validation strategies for projects and working closely with project managers to meet the timelines
- Developing and writing validation project plans, master validation protocols, traceability matrices and summary reports by providing instructions and scientific rationale for the performance of validation studies
- Leading fellow technical and analysis team members in ensuring compliance with corporate quality standards and requirements
- Facilitating the translation of new and revised corporate quality requirements into practical application for revising, updating and adding new documentation to an existing computer system validation package
- Coordinating the testing efforts of the IT and business teams with regards to requirements, resource planning, test coverage, test strategies
- Advising the business SMEs and IT Applications staff to create thorough, accurate and comprehensive test scripts
- Developing and maintaining test metrics and generate reports for management use in determining project and applications test status
- Coordinating and interacting with all affected personnel in the execution of test scripts and validation protocols and gathering of test data and ensuring all protocol executions are documented and recorded in accordance with company quality policies, quality standards and SOPs
- Analyzing data to determine if it meets protocol acceptance criteria and document deviations as necessary and Ensuring all final reports are documented and approved
- Maintaining accountability for completion of required training for the position
Requirements:
- Minimum of 3 years of experience in validation and software testing in Pharmaceutical or Bio-Tech industry is required (regulated by government agencies, ie FDA, EMEA, Japan Health Authorities, Canadian Health Authorities, etc.)
- Experience in pharmaceutical regulatory is mandatory
- Track record in validating global solutions interfacing with other systems and involving multinational teams that are geographically distributed is mandatory
- Participation in at least one full life cycle implementation and production support is required
- Good understanding of FDA and GxP regulations pertaining to computer systems validation (CFR Part 11) and GxP is required
- Exceptional interpersonal, writing and communication skills and dedication to customer service and satisfaction are essential
- Experience participating in external regulatory audit/inspection teams is preferred
- Travel: up to 20-30% of the time, possibly overseas
- Working language: English
Are you available immediately, have experience working within a Life Science company? Please send your complete CV (Word documents preferred)
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Sonstiges