Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.
Vakante Jobangebote finden Sie unter Projekte.
Senior Qualification & Validation Engineer
Eingestellt von Edelway
Gesuchte Skills: Sales, Engineer, Engineering, Affiliate
Projektbeschreibung
Senior Qualification & Validation Engineer
Edelway AG is a Swiss IT Services Consultancy. One of our best clients, a global multinational company based in the Bern area, is currently looking for a Senior Qualification & Validation Engineer to join them on a long term basis.
Start Date: ASAP
Working Language: English
Rate: Excellent
THE ROLE
*Planning and implementation of qualification/validation activities and projects of new and existing computer systems according
*Internal and external requirements for all departments within the client's EMEA and in particular the EMEA distribution organisation (standard sales, loan & consignment operations in the country affiliates)
*Advisory and support of application owners to build and maintain GDP conform systems
*Approving specific computer system validation documentation and acting as software quality assurance
*Definition of the global CSV framework in collaboration with the regional CSV stakeholders in EMEA
*Approving change requests and monitor the necessary activities for the requalification/validation after changes, deviations, etc.
*Serves as technical expert for the validation process and responsibilities to ensure compliance
*Resolve & manage technical operational problems in the area of expertise
*Suggest and be able to implement innovation and continuous improvement within the validation process
*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.
*Facilitates, encourage and coordinate continuous improvement with respect to validation activities.
*Support in the planning, coordination and execution of activities for sales operations affiliate projects (eg design review, qualification of IT systems and infrastructure needs, validation of processes and software, etc.).
*Develop relationships with the operation managers in these countries and acquire a deep understanding of their processes and needs.
YOUR PROFILE
*Working experience in validating computer systems for use in an FDA regulated environment or similar *A degree in an appropriate discipline (eg Engineering, Information Systems, or an IT qualification) with a broad technical/educational skills base and substantial related experience
*An understanding of GDP, Compliance, Validation Practices including regulatory expectations.
*A background in and know-how of distribution/logistics operations is preferred
*Capable of leading and giving direction to validation projects and teams
*Active team member in validation activities methodology/certification requirements
If it sounds like your next challenge, please send us your CV and we will contact you shortly to discuss it further.
Edelway AG is a Swiss IT Services Consultancy. One of our best clients, a global multinational company based in the Bern area, is currently looking for a Senior Qualification & Validation Engineer to join them on a long term basis.
Start Date: ASAP
Working Language: English
Rate: Excellent
THE ROLE
*Planning and implementation of qualification/validation activities and projects of new and existing computer systems according
*Internal and external requirements for all departments within the client's EMEA and in particular the EMEA distribution organisation (standard sales, loan & consignment operations in the country affiliates)
*Advisory and support of application owners to build and maintain GDP conform systems
*Approving specific computer system validation documentation and acting as software quality assurance
*Definition of the global CSV framework in collaboration with the regional CSV stakeholders in EMEA
*Approving change requests and monitor the necessary activities for the requalification/validation after changes, deviations, etc.
*Serves as technical expert for the validation process and responsibilities to ensure compliance
*Resolve & manage technical operational problems in the area of expertise
*Suggest and be able to implement innovation and continuous improvement within the validation process
*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.
*Facilitates, encourage and coordinate continuous improvement with respect to validation activities.
*Support in the planning, coordination and execution of activities for sales operations affiliate projects (eg design review, qualification of IT systems and infrastructure needs, validation of processes and software, etc.).
*Develop relationships with the operation managers in these countries and acquire a deep understanding of their processes and needs.
YOUR PROFILE
*Working experience in validating computer systems for use in an FDA regulated environment or similar *A degree in an appropriate discipline (eg Engineering, Information Systems, or an IT qualification) with a broad technical/educational skills base and substantial related experience
*An understanding of GDP, Compliance, Validation Practices including regulatory expectations.
*A background in and know-how of distribution/logistics operations is preferred
*Capable of leading and giving direction to validation projects and teams
*Active team member in validation activities methodology/certification requirements
If it sounds like your next challenge, please send us your CV and we will contact you shortly to discuss it further.
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Marketing/Vertrieb, Ingenieurwesen/Technik