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Quality and Validation Engineer
Eingestellt von Michael Bailey Associates - Zurich
Gesuchte Skills: Engineer, Engineering, Client
Projektbeschreibung
Qualification and Validation Engineer
For our life science client in Ticino, we are currently seeking a Validation Engineer
Start Date: ASAP
Duration: 3 months with possibility of extension
Work Load: 60%
Location: Ticino area
Language: English and Italian
Primary Tasks:
Serves as technical expert for the Validation process and responsibilities to ensure compliance
Review and approve Validation Master Plans, Protocols, Summary Reports and other documentation associated with validations, as appropriate for each validation exercise.
Resolves & manages technical operational problems in area of expertise.
Suggest and sometimes may implement innovation and continuous improvement within the Validation process.
Manages relationships externally and internally.
Builds cross-functional and cross-departmental support, fostering overall effectiveness.
Influences and persuades so as to bring about technical and process improvements.
Ensure that all validation activities are carried out and reported in a timely manner.
Keep management informed of significant quality issues in a manner commensurate with the potential impact of the issue on public health, employee health & safety, company operations, and/or the environment.
Experience Needed:
Minimum of 2 - 5 years working in a regulated industry a minimum 2 of which have been spent carrying out validations
Experience within the Pharmaceutical or Life Science industry
Process knowledge and documentation
Desirable:
In depth knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry.
High understanding of 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.
Education:
Qualification in an appropriate discipline (eg Engineering, Information Systems, or Life Science with additional IT qualification) with a broad technical/educational skills base.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
For our life science client in Ticino, we are currently seeking a Validation Engineer
Start Date: ASAP
Duration: 3 months with possibility of extension
Work Load: 60%
Location: Ticino area
Language: English and Italian
Primary Tasks:
Serves as technical expert for the Validation process and responsibilities to ensure compliance
Review and approve Validation Master Plans, Protocols, Summary Reports and other documentation associated with validations, as appropriate for each validation exercise.
Resolves & manages technical operational problems in area of expertise.
Suggest and sometimes may implement innovation and continuous improvement within the Validation process.
Manages relationships externally and internally.
Builds cross-functional and cross-departmental support, fostering overall effectiveness.
Influences and persuades so as to bring about technical and process improvements.
Ensure that all validation activities are carried out and reported in a timely manner.
Keep management informed of significant quality issues in a manner commensurate with the potential impact of the issue on public health, employee health & safety, company operations, and/or the environment.
Experience Needed:
Minimum of 2 - 5 years working in a regulated industry a minimum 2 of which have been spent carrying out validations
Experience within the Pharmaceutical or Life Science industry
Process knowledge and documentation
Desirable:
In depth knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry.
High understanding of 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.
Education:
Qualification in an appropriate discipline (eg Engineering, Information Systems, or Life Science with additional IT qualification) with a broad technical/educational skills base.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Ingenieurwesen/Technik