Description
QA CSV Engineer required for a 12-month contract with a global biotech company in Dublin.The QAV CSV engineer will be providing compliance oversite at PAS SFAT's, qualification testing compliance review and approvals including RTM's and Summary Reports.
Daily responsibilities include:
- Performing leveraging assessments.
- Automation Change Control participation, review and approval.
- Providing compliance oversite for life cycle documentation, ie DS, FS, HDS etc
- Responsible for coordinating the paper-based documentation under compliant processes.
- Ensure filing and maintaining all test records under the GMP regulations and standards.
- Working with CSV to resolve document issues ensuring that the Incident Logs are assessed and corrective actions are implemented in compliant behaviour.
- Ensuring the quality of all Quality Records, physical and electronic versions.
- Reviewing Design documents and ensure that they comply with the GDP and GMP requirements within the scope of CMP.
- Working with the CSV and automation teams to choose and implement a solution for raised issues during testing.
- Ensure maintaining accurate and detailed test records, to achieve understandable records audit ready.
- Must understand and demonstrate compliance with all applicable regulatory requirements.
- Testing documents quality review.
- Incident Log Sheets review and approvals.
- Design Documents review and approvals.
- Updating trackers for documents review.
- Support problem solving for testing and ILSs documentation issues.
- Decision making for all quality related topics.
- Following up with the teams for testing completion.
- Tracking testing documents review.
- Packing and collecting the testing documents in correct order.