Beschreibung
Validation SME/Process Validation Expert - Solothurn Canton, Switzerland
Initial contract until
Skills required -
- Experience in Process Validation, Medical Devices, Mechanical and Chemical Processes, 21 FDA 820
Required degree/certificates:
- Quality Management
Specific technical skills (please detail):
- 21 FDA 820
- ISO 13485
- Medical Device experience is a plus
Role -
- Responsible and collecting the deliveries of the site GRQP activities
- Reports and Support to the EMEA Validation Manager in the GRQP activities
- 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 client Validation Policies and Procedures are addressed.
Primary Tasks and Responsibilities
- Managing Complexity/Technical Accountability
- Serves as technical expert for the Validation process and responsibilities to ensure compliance
- Continuous Learning/Managing Risk
- 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.
- Facilitates successful team behavior within Quality Systems and across functional areas
- Manages relationships externally and internally.
- Builds cross-functional and cross-departmental support, fostering overall effectiveness
- Fosters harmony within Quality Systems.
- Influences and persuades so as to bring about technical and process improvements.
- 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.