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Qualification & Validation Engineers
Eingestellt von Harvey Nash IT Recruitment Switzerland
Gesuchte Skills: Engineering, Support
Projektbeschreibung
On behalf of one major client in the Pharma industry, Harvey Nash is currently looking for Qualification and Validation Engineers for contract assignments in various Swiss locations.
Project description
- Provides support for the validation activities associated with equipment, reagents, facilities, cleaning, test methods, and environment ensuring that all compliance issues and requirements in terms of Validation Policies and Procedures are addressed
- Technical expert for the Validation process and responsibilities to ensure compliance
- Risk management
- Implements initiatives in the Validation Process that will deliver customer value
- Manages relationships externally and internally
- Ensure accuracy and maintenance of the Validation Master List
- Create Validation Master Plans, Protocols, Summary Reports and other documentation associated with validations, as appropriate
- Ensure all validation activities and documents are authorized and appropriate compliance approval is gained
- Ensure compliance through assisting in audits
- Keep Management informed of significant quality issues. Assess potential impact of issue on public health, employee health & Safety, operations and environment.
- Ensure compliance through assisting in audits
Special Requirements
- Process knowledge and documentation
- Knowledge of 21 CFR 820, 21 CFR 11 and EU regulations associated with the medical device industry
- High expertise with GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations
- Working experience of validation computer systems for use in a FDA regulated environment
- 2 years experience working in validated environments, GxP and 21 CFR part 11
- Qualification (engineering, IT, Life Science) combined with IT qualification.
Project scope
- Start: ASAP OR 01.06.13
- End: 31.12.13 (extension very likely)
- Location: Solothurn (Switzerland) or TICINO
- Languages: German and English fluent for Solothurn or English and Italian for TICINO
Interested? Then please send your complete CV (word documents preferred) or contact me directly under.
I am looking forward to receiving your application.
Project description
- Provides support for the validation activities associated with equipment, reagents, facilities, cleaning, test methods, and environment ensuring that all compliance issues and requirements in terms of Validation Policies and Procedures are addressed
- Technical expert for the Validation process and responsibilities to ensure compliance
- Risk management
- Implements initiatives in the Validation Process that will deliver customer value
- Manages relationships externally and internally
- Ensure accuracy and maintenance of the Validation Master List
- Create Validation Master Plans, Protocols, Summary Reports and other documentation associated with validations, as appropriate
- Ensure all validation activities and documents are authorized and appropriate compliance approval is gained
- Ensure compliance through assisting in audits
- Keep Management informed of significant quality issues. Assess potential impact of issue on public health, employee health & Safety, operations and environment.
- Ensure compliance through assisting in audits
Special Requirements
- Process knowledge and documentation
- Knowledge of 21 CFR 820, 21 CFR 11 and EU regulations associated with the medical device industry
- High expertise with GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations
- Working experience of validation computer systems for use in a FDA regulated environment
- 2 years experience working in validated environments, GxP and 21 CFR part 11
- Qualification (engineering, IT, Life Science) combined with IT qualification.
Project scope
- Start: ASAP OR 01.06.13
- End: 31.12.13 (extension very likely)
- Location: Solothurn (Switzerland) or TICINO
- Languages: German and English fluent for Solothurn or English and Italian for TICINO
Interested? Then please send your complete CV (word documents preferred) or contact me directly under.
I am looking forward to receiving your application.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges