Beschreibung
Task:- 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.
- Ensure accuracy and maintenance of the customers Validation Master List.
- 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. ?
- Through effective communication and training initiatives develop staff in projects and validation teams to ensure that validation projects are carried out in accordance with customers Policies and Procedures.
- Facilitates, encourage and coordinate continuous improvement with respect to validation activities.
- 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
Requirements (Must have):
- Knowledge of bespoke validation.
- Process knowledge and documentation.
- 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.
- Qualification in an appropriate discipline (e.g. Engineering, Information Systems, or Life Science with additional IT qualification) with a broad technical/educational skills base
- Minimum of 2 years working in a regulated environment a minimum 1 of which has been spent carrying out validation and/or testing activities.
- Desirable: ?A degree in an appropriate discipline (e.g. Engineering, Information Systems, or an IT qualification) with a broad technical/educational skills base and substantial related experience ?Minimum of 2 - 5 years working in a regulated industry a minimum 2 of which has been spent carrying out validations.
Beginn: 13.01.2014
Dauer: 31.03.2014
Branche: Medizin/Healthcare