- 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.
- 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 Recruitment T: +353 91 455305 E: email@example.com
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