Computer Systems Validation

Sigmar Recruitment

Galway

Responsibilities: Participating and developing the validation program onsite, coordinating testing for software and manufacturing process systems onsite in line with cGMPs and industry standards. Aid software system developers and SMEs in designing, documenting, performing and improving verification tests ensuring validation program meets requirements of FDA (21CFR11), ISO, PDMA and GAMP 5 where appropriate. Define validation plans with quality department and participate in team projects for installation, validation, troubleshooting and system update activities. Provide information on systems validation to other departments at early stages. Use your knowledge of validation principles and guidelines to help with risk assessments, CAPAs and change controls. Requirements: Level 8 or higher degree in engineering, science or similar with 2 to 3 years’ experience in medical device, pharma or similarly regulated environment. Knowledge or GAMP5, FDA (21CFR11), ISO, PDMA. Knowledge of software development methodologies. Knowledge of ERP, database systems and architecture. Knowledge of PLC programming methodologies and systems. To apply for this position please contact James Porter at Sigmar RecruitmentT: +353 91 455305E: jporter@sigmar.ie. All applications will be treated with the strictest of confidence. Sigmar will never forward your CV to a third party without prior consent. Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website. This job originally appeared on RecruitIreland.com.

2048 days ago