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Validation Expert (SW QA, GxP, Validation, Pharma, Test)
Eingestellt von Adecco IT
Gesuchte Skills: Support
Projektbeschreibung
Adecco IT is currently looking for a VALIDATION PROFESSIONAL on behalf of its client, a major global company in the Healthcare sector located in Basel.
The qualified person 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
QUALIFICATIONS/REQUIREMENTS:
- Assists in the development, planning, directing and tracking of the validation of the GSL computer system
- Maintains production computer systems in a validated state, monitors all modifications or changes to systems or processes, initiates change control/revalidation as required and ensures a continual state of inspection readiness with regard to GxP.
- Works with project teams to come up with validation strategies for projects and works closely with project managers to meet the timelines.
- Develops and writes validation project plans, master validation protocols, traceability matrices and summary reports by providing instructions and scientific rationale for the performance of validation studies.
- Leads fellow technical and analysis team members in ensuring compliance with corporate quality standards and requirements.
- Facilitates 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.
- Coordinates the testing efforts of the IT and business teams with regards to requirements, resource planning, test coverage, test strategies.
- Advises the business SMEs and IT Applications staff to create thorough, accurate test scripts.
- Develops and maintains test metrics and generate reports for management use in determining project and applications test status.
- Coordinates and interacts with all affected personnel in the execution of test scripts and validation protocols and gathering of test data.
- Ensure all protocol executions are documented and recorded in accordance with company quality policies, quality standards and SOPs.
- Analyzes data to determine if it meets protocol acceptance criteria and document deviations as necessary. Ensure all final reports are documented and approved.
- Maintain accountability for completion of required training for the position.
SKILLS
- 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/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.
- Experience participating in external regulatory audit/inspection teams is preferred
- Can work independently without requiring permanent guidance and direction
MISCELLANEOUS:
- START: ASAP
- END: 30.12.2014
- Workload: 100%
The qualified person 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
QUALIFICATIONS/REQUIREMENTS:
- Assists in the development, planning, directing and tracking of the validation of the GSL computer system
- Maintains production computer systems in a validated state, monitors all modifications or changes to systems or processes, initiates change control/revalidation as required and ensures a continual state of inspection readiness with regard to GxP.
- Works with project teams to come up with validation strategies for projects and works closely with project managers to meet the timelines.
- Develops and writes validation project plans, master validation protocols, traceability matrices and summary reports by providing instructions and scientific rationale for the performance of validation studies.
- Leads fellow technical and analysis team members in ensuring compliance with corporate quality standards and requirements.
- Facilitates 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.
- Coordinates the testing efforts of the IT and business teams with regards to requirements, resource planning, test coverage, test strategies.
- Advises the business SMEs and IT Applications staff to create thorough, accurate test scripts.
- Develops and maintains test metrics and generate reports for management use in determining project and applications test status.
- Coordinates and interacts with all affected personnel in the execution of test scripts and validation protocols and gathering of test data.
- Ensure all protocol executions are documented and recorded in accordance with company quality policies, quality standards and SOPs.
- Analyzes data to determine if it meets protocol acceptance criteria and document deviations as necessary. Ensure all final reports are documented and approved.
- Maintain accountability for completion of required training for the position.
SKILLS
- 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/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.
- Experience participating in external regulatory audit/inspection teams is preferred
- Can work independently without requiring permanent guidance and direction
MISCELLANEOUS:
- START: ASAP
- END: 30.12.2014
- Workload: 100%
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Sonstiges