This position is no longer open for applications

The QC Data reviewer is responsible for peer review of Laboratory test data, GMP documentation and ensuring that the data review in the group is prioritized to meet required timelines.

QC Data Reviewer will be primarily responsible for performing an independent technical review of all test results and procedure compliance in order to issue test results. The reviewer will work with group technical leads to ensure site timelines are being met for all review work within the group, to ensure timely issuance of results for project and batch release.

• Evaluates laboratory data for compliance with analytical methods and SOPs and to GMP.
• Review of laboratory raw data from in process, batch release and stability studies against test method requirements and specifications to strict timelines.
• Review of stability raw data and reports against relevant test methods, protocols and procedures.
• Review/ Preparation of batch release, in process and stability trend data and reporting on same.
• Reviews sample results for completeness and accurate representation of the data and report findings.
• Monitor and follow-up on QC department ETS documents (including Deviations, LIRs and Change Controls) ensuring compliance with timelines and reporting on same, including trending.
• Partaking in Audits
• Communicates with laboratory staff to proactively address the quality of laboratory documentation.
• Reviewing and suggesting improvements to processes and procedures for Quality Control function
• Supports the training of laboratory staff on compliance and data reviews.
• Administering Good
• Documentation Practices training and ensuring that proper GDP training is understood and followed by lab staffConducts SOP review and writing.
• Perform other duties and projects as assigned