Description
The successful candidate will be responsible for developing a process for the validation of computer and/or automation systems compliance in line with cGMPs, Annex 11, GAMP and 21 CFR Part 11.Key responsibilities/activities of the position:
- Develop a process for the validation of computer and automation systems to ensure compliance of required regulatory requirements.
- To Coordinates and executes training of required personnel on the computer and automation systems validation procedures and methodology.
- Support activities include, but are not limited to, SOP creation, documentation review and approval including change controls, assessment plans, risk assessment reports, compliance plans, user requirements, system and user acceptance testing protocols, traceability matrix, error reports/defect report forms and summary reports.
- Participates on cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups.
- Contributes directly to the completion of projects through the management of assigned contract personnel, development and execution of validation change control documents, and development and review of protocols, reports and data tables generated by peers and contract personnel.
- As required, prepares summaries of validation testing for regulatory submissions and presents validations to regulatory agencies.
- Serves as an information resource for computer systems validation to validation engineers, contractors and vendors.
Educational / Professional Details Required:
- Bachelors degree in a technical, scientific or related field is preferred.
- Min 6 years of related industry experience
- Min 3 years of experience in CSV system development life cycle is required.
- Strong knowledge of system development life cycle is required.
- The ability to travel up to approx. 10% (domestic and international) is required.
This is an excellent opportunity to join a fast paced, innovative company with competitive hourly rates. To apply for this position please contact Sarah Irvine on . We also offer €200 worth of vouchers for any successful referrals so if you know of anyone who may be available please feel free to get in touch.