Beschreibung
Desirable:
- Working experience validating computer systems for use in a 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
- Understanding of GDP, Compliance, Validation Practices including Regulatory expectations.
- Background in and know-how of Distribution/Logistics Operations preferred
- Capable of leading and giving direction to Validation Projects and Teams
- Active team member in Validation activities Methodology/Certification Requirements
Overall Responsibilities:
- Planning and implementation of qualification/validation activities and projects of new and existing computer systems according to
- internal and external requirements for all departments within DePuySynthes 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
- Resolves & manages technical operational problems in area of expertise
- Suggest and sometimes may 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.
Extended Duties:
Support to 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 excellent relationship to the Operation Managers in the countries and a deep understanding of their processes and needs.