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Validation Engineer
Eingestellt von Randstad (Schweiz) AG
Gesuchte Skills: Engineering, Support, Engineer
Projektbeschreibung
Randstad Professionals is actively looking for Validation engineers to join their pharmaceutical in different locations throughout Switzerland. The jobholder will provide support regarding validation activities associated with Functional and Physical test methods, ensuring that all compliance issues and requirements of the client's Test Method Validation Policies and Procedures are addressed.
The focus of the project will be to remediate the client's validation approach as well as the creation of test method validation procedures. In order to do this, it will also be necessary to analyze and investigate the current status of the used methods. The contract duration is until March 2016 but will very likely be extended after this date.
Primary Tasks and Responsibilities include:
Serve as the technical expert for the Test Method Validation process to ensure compliance
Suggest innovative and continuous improvement ideas within the Test Method Validation processes
Write and review Validation Master Plans, Test Method Procedures, Protocols, Summary Reports and other documentation associated with Test Method Validations, as appropriate for each validation exercise.
Ensure all validation activities and documents are authorized and appropriate compliance approval is gained.
Your profile:
Expert knowledge of Functional and Physical Test Method Validation.
Working experience of validation and test method validations for use in a FDA regulated environment
Manufacturing and Medical Device production process knowledge.
In depth knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry (ISO 13485, ISO 9001 and technical norms related to validation), knowledge of GHTF.
High understanding of GMP, GDP, GXP, Compliance, Validation Practices.
Desirable:
A degree in an appropriate discipline (eg Engineering, life-science, natural sciences) with a broad technical/educational skill base and substantial related experience
Minimum of 2-5 years working in a regulated industry including 2 of which has been spent carrying out validations.
Soft skills:
- Some flexibility in working hours is required
- Must be able to work on multiple simultaneous tasks with limited supervision
- Quick learner, motivated self-starter;
- Excellent customer service, interpersonal, communication and team collaboration skills;
- Able to follow change management for internal guidelines.
- Language proficiencies: -English and Swiss German spoken and written
If you're up for a new project and fulfil these requirements, don't hesitate to send in your application!
Good to know you
Charlotte
The focus of the project will be to remediate the client's validation approach as well as the creation of test method validation procedures. In order to do this, it will also be necessary to analyze and investigate the current status of the used methods. The contract duration is until March 2016 but will very likely be extended after this date.
Primary Tasks and Responsibilities include:
Serve as the technical expert for the Test Method Validation process to ensure compliance
Suggest innovative and continuous improvement ideas within the Test Method Validation processes
Write and review Validation Master Plans, Test Method Procedures, Protocols, Summary Reports and other documentation associated with Test Method Validations, as appropriate for each validation exercise.
Ensure all validation activities and documents are authorized and appropriate compliance approval is gained.
Your profile:
Expert knowledge of Functional and Physical Test Method Validation.
Working experience of validation and test method validations for use in a FDA regulated environment
Manufacturing and Medical Device production process knowledge.
In depth knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry (ISO 13485, ISO 9001 and technical norms related to validation), knowledge of GHTF.
High understanding of GMP, GDP, GXP, Compliance, Validation Practices.
Desirable:
A degree in an appropriate discipline (eg Engineering, life-science, natural sciences) with a broad technical/educational skill base and substantial related experience
Minimum of 2-5 years working in a regulated industry including 2 of which has been spent carrying out validations.
Soft skills:
- Some flexibility in working hours is required
- Must be able to work on multiple simultaneous tasks with limited supervision
- Quick learner, motivated self-starter;
- Excellent customer service, interpersonal, communication and team collaboration skills;
- Able to follow change management for internal guidelines.
- Language proficiencies: -English and Swiss German spoken and written
If you're up for a new project and fulfil these requirements, don't hesitate to send in your application!
Good to know you
Charlotte
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges