CSV Engineer

QA Resources is looking for a CSV Engineer on behalf of a leading API company based in Cork. This is an initial 12-month contract role. This is a fully onsite position.

Overview:

Person responsible to ensure that validation, risk, and data integrity assessment activities are applicable to the Computerized Systems conform the principles of this procedure.

Periodically, the Validation Lead (VL) should perform the review of the Computerized System to verify that critical data has not been compromised and that the aspects designed to assure data integrity (electronic records and signatures subjected to 21 CFR Part 11 compliance, electronic audit trails, data backups, security and access permissions, user training, operating procedures, and any change control validations) are adequately maintained. These aspects should be evaluated to identify any present or potential breaches of data integrity.

• Ensure completeness and consistency of validation life-cycle documentation for GMP Computerized Systems;
• Ensure that all GMP Computerized Systems operate as intended and meet regulatory requirements;
• Perform and review assessments / audit reports, answer to findings and take appropriate actions to ensure GMP compliance;
• Coordinate inputs from other areas and PO e SO (e.g., Quality, Finance, Information Security, Safety, Legal, others).

Interested candidates should submit an updated CV.

Please click the link below to apply, or alternatively send an up to date CV to [email protected]

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***