Jun 4, 2012
Responsible for the reviewing and verification of all compounding, filling and packaging batch documents and in process testing reports supporting Sterile Products Production to ensure completeness, accuracy and compliance to all established Apotex procedures and GMP requirements.
1. Review and approve applicable sterile product production documents according to the priorities established by the business and according to the criticality of any issues.
2. Ensure that the compounding, filling and packaging operations for sterile product lines follow the established document and procedural requirements including verification of critical parameters as required
3. Report any deviations found during review of sterile product production documents to the Supervisor, QA SAIP / Manager, QA Sterility Assurance. Ensure all corrections are made in the appropriate manner and ensure that all deviations are fully explained and supported by the necessary documentation.
4. Review all in-process testing worksheets for sterile products and ensure tests were performed according to the required procedures/methods and that all results are within established specifications.
5. Perform “Results Recording” in SAP for all applicable sterile product characteristics.
6. Support quality trending for all related operations, including critical EM monitoring and personnel monitoring.
7. Record the receipt, the review and the release of all sterile product batches in QA Database to ensure that batches are appropriately processed through the supply chain in order to meet compliance and business requirements.
8. Ensure that all work is performed in full compliance with Good Manufacturing Practices, Good Laboratory Practices and Standard Operating Procedures including aseptic behaviour and provides input into unapproved interventions.
9. Support validation programs as required by gathering necessary data from equipment cleaning logs, complete the Validation Status Product Release Check-Sheet and verify the data against the Swabbing Requirements list as per Apotex procedures and GMP requirements.
10. Ensure Q-Notifications issued for each sterile product bulk batch in SAP, are set to S&L status prior to forwarding the documents to QAPR for release.
11. Verify the Active Add date in SAP against the sterile product production document and issue a Q-Notification if required. Complete the usage decision in SAP.
12. Document all required corrections to in-process tests for sterile product and coordinate with SAIP Coordinators and Production to ensure all corrections are completed in compliance with Apotex procedures and GMP requirements.
13. Provide necessary training to new QASA Document Reviewers and QASAIP personnel as required.
14. Any other duties as assigned.
- Community College Diploma / University degree (or equivalent) in a related discipline
- Minimum 2 years experience in a pharmaceutical quality and/or production environment.
- Must be familiar with the GMP and quality requirements
- Good command of the English language (both written and verbal)
- Excellent organizational skills and ability to manage time effectively
- Ability to follow instructions according to written procedures
- Ability to manage multiple priorities in a fast-paced and changing environment
- Knowledge of GMP required
- Familiarity with Word, Excel, Access would be an asset
- Flexibility to work shifts.
- 11 months ago