Job Description
We are currently seeking a QPS Officer to join our team.
The Position
- Assists the Quality Services Manager and Qualified Persons in the day-to-day operation to support the batch release activities to ensure that each batch has been manufactured and checked in compliance with the respective laws in Member States and in accordance with the requirements of the Marketing Authorisation
- Assists the Quality Services Manager in the management of the quality system according to EU GMP and GDP
Tasks and Responsibilities
- Review of transit temperature monitoring records for all batches and/ or samples received and dispatched
- Compilation of batch manufacturing records, sampling forms and documents required for batch documentation review prior to QP release
- Verification of Packaging Component Artwork compliance
- Batch manufacturing documentation review
- Preparation and issuance of batch packaging records
- Review of secondary re-packaging documentation generated at APL Swift Services (Malta) Ltd. prior and post the execution of the process
- Review of secondary re-packaging documentation generated by approved European secondary packaging sites post the execution of the process
- Ensure that products are re-packaged and stored according to the appropriate documentation to comply with EU GMP
- To liaise with the QA department to ensure FMD Compliance for all re-packaging operations
- Registration and approval of products for secondary repackaging on JEKSON Reetrak system
- Approval of batch requests for secondary repackaging on JEKSON Reetrak system
- Maintain records of all quality documentation
- Assists Quality Assurance Manager in quality investigations
- Carry out other duties as may reasonably be required
