Validation Engineer

Inverness  ‐ Onsite
This project has been archived and is not accepting more applications.
Browse open projects on our job board.

Keywords

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
Start date
04/2013
Duration
3.5
From
Real Staffing
Published at
24.04.2013
Project ID:
526152
Contract type
Freelance
To apply to this project you must log in.
Register