Our client, a global leader in the Pharmaceutical industry, is looking for a QA Documentation Specialist to join its team in Malta.
- Detailed review of analytical data for raw materials, intermediates, final product, stability studies and method transfers / validations for compliance with cGMP, internal SOPs and Specifications.
- Identify and report any deviations from the method as well as OOS / OOT
- Perform the review of documentation of analytical results abiding to the most current GMP regulations.
- Identify and report any deviations from the method as well as OOS / OOT to their Senior Documentation Specialist, QA Manager, QP and Coordinator/Head of QC, and support the related investigations
- Ensure that only batches that have been completely reviewed, do not have any open OOS/ OOT or deviations are passed on for release.
- Guide and train QC analysts and specialists in good documentation practices
- Maintain and update relevant SOPs for data review and reporting as needed
- To report to the Senior Documentation Specialist any deviations from methods/SOPs/processes and cGMP rules.
The essential requirement for this post is lab experience, as the person holding this role will be reviewing analysis performed by lab Analysts.