Description
To provide validation support for the validation activities associated with computer systems ensuring that all compliance issues and requirements of Validation Policies and Procedures are addressed.Responsibilities:
* To coordinate projects associated with the validation of computer systems [IT, Control and End user] as directed
* To organize and lead Validation working parties associated with computer systems, providing a timely validation coordination service to Project Managers or identified Project Leaders
* To provide support and input to CSV Team Leader to work towards a common computer systems validation process
* To provide information on current regulatory and company standards that must be met to achieve and maintain compliance
* To prepare and issue Validation Master Plans, Protocols, Summary Reports and other documentation associated with validation of computer systems, as appropriate for each validation exercise
* To ensure all validation activities and documents are authorised and appropriate compliance approval is gained
* To ensure that all validation activities are carried out and reported in a timely manner
* To compile a Validation Master File for each computer system as appropriate.
* To assure compliance through assisting in audits
* Through effective communication and training initiatives develop staff within projects and validation teams to ensure that validation projects are carried out in accordance with LifeScan Policies and Procedures
* To schedule and complete validation reviews for each computer system.
* To facilitate, encourage and coordinate continuous improvement with respect to validation activities within the team
* 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
Skills / Knowledge:
Required:
* Previous experience working in a regulated industry carrying out computer systems validation and/or testing activities
* Minimum of two years working in an FDA regulated environment carrying out computer systems validation and/or testing activities
* Knowledge of bespoke computer software and/or hardware specification, testing and documentation
* Knowledge of the specification, testing and implementation of automated equipment and SCADA systems for businesses within a FDA regulated industry.
* Experience in document authoring of validation deliverables.
* Self-directed; ability to work with minimal direct supervision
* Verbal and written communications
* Negotiation
* Problem-solving
* Proactive problem resolution
* Change Management
Desirable:
* In depth knowledge of 21 CFR 820, 21 CFR 11, ISO 13485:2003 and European regulations associated with the medical device industry
* In depth knowledge of GAMP 5
To find out more about Real please visit www.realstaffing.com