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Validation Engineer
Eingestellt von Harvey Nash IT Recruitment Switzerland
Gesuchte Skills: Engineer, Support
Projektbeschreibung
Role: Validation Engineer- Grenchen
Place of work: Grenchen
Project Start date: 03.01.2017
Project End date: 30.06.2017
Workload/weekly working hours: 100%/40 hours
CSV/Validation:
* Originate TM assessment including protocol and plan for outlined CCPs or other control points. Coordinate required actions and assure that TMV are completed on time
* Originate and approval of Test Method Validations including of determination of sample size and worst case parts
* Establish adequate documentation for CAPA action. Conduct transfers of TMV protocols and plans
* Originate requested documents for validation and computer system validation with support of Subject Matter Experts. Coordinate actions and assure that deliverables are completed on time
General Description:
* To provide support for the validation activities associated with equipment, reagents, facilities, cleaning, test methods, and environment ensuring that all compliance issues and requirements of Johnson & Johnson Validation Policies and Procedures are addressed.
Primary Tasks and Responsibilities
* Serves as technical expert for the Validation process and responsibilities to ensure compliance. Resolves & manages technical operational problems in area of expertise
* Suggest and sometimes may implement innovation and continuous improvement within the Validation process
* Implements initiatives in the Validation Process that will deliver customer value at lowest cost.
* Review and approve Validation Master Plans, Protocols, Summary Reports and other documentation associated with validations, as appropriate for each validation exercise.
* Ensure all validation activities and documents are authorized and appropriate compliance approval is gained.
* Ensure that all validation activities are carried out and reported in a timely manner. Ensure compliance through assisting in audits.
* Through effective communication and training initiatives develop staff in projects and validation teams to ensure that validation projects are carried out in accordance with Johnson & Johnson Policies and Procedures.
* Facilitates, encourage and coordinate continuous improvement with respect to validation activities.
* Keep management informed of significant quality issues in a manner commensurate with the potential impact of the issue on public health, employee health
Place of work: Grenchen
Project Start date: 03.01.2017
Project End date: 30.06.2017
Workload/weekly working hours: 100%/40 hours
CSV/Validation:
* Originate TM assessment including protocol and plan for outlined CCPs or other control points. Coordinate required actions and assure that TMV are completed on time
* Originate and approval of Test Method Validations including of determination of sample size and worst case parts
* Establish adequate documentation for CAPA action. Conduct transfers of TMV protocols and plans
* Originate requested documents for validation and computer system validation with support of Subject Matter Experts. Coordinate actions and assure that deliverables are completed on time
General Description:
* To provide support for the validation activities associated with equipment, reagents, facilities, cleaning, test methods, and environment ensuring that all compliance issues and requirements of Johnson & Johnson Validation Policies and Procedures are addressed.
Primary Tasks and Responsibilities
* Serves as technical expert for the Validation process and responsibilities to ensure compliance. Resolves & manages technical operational problems in area of expertise
* Suggest and sometimes may implement innovation and continuous improvement within the Validation process
* Implements initiatives in the Validation Process that will deliver customer value at lowest cost.
* Review and approve Validation Master Plans, Protocols, Summary Reports and other documentation associated with validations, as appropriate for each validation exercise.
* Ensure all validation activities and documents are authorized and appropriate compliance approval is gained.
* Ensure that all validation activities are carried out and reported in a timely manner. Ensure compliance through assisting in audits.
* Through effective communication and training initiatives develop staff in projects and validation teams to ensure that validation projects are carried out in accordance with Johnson & Johnson Policies and Procedures.
* Facilitates, encourage and coordinate continuous improvement with respect to validation activities.
* Keep management informed of significant quality issues in a manner commensurate with the potential impact of the issue on public health, employee health
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges