Job Description

In general, ensure that the company complies with Eudralex, ICH guidelines and EU regulations and directives. Some responsibilities are listed below. However, this list is not exhaustive 1. Communicate effectively and collaborate in QC activities in the microbiology laboratory with the QC Assistant Manager Microbiology. 2. Participate in the development and installation of a KPI system in the microbiology laboratory assisting the QC Manager 3. Manage and schedule routine and annual maintenance, troubleshooting and of all analytical equipment and analytical practices and procedures in order to uphold continuous improvement in the microbiology laboratory. 4. Obey to work schedules and ensure that planned work and tasks entrusted are effectively adhered to in the microbiology laboratory. 5. Manage and maintain all laboratory software in the microbiology laboratory. 6. Troubleshoot all QC analytical methods, equipment and calibrations in the microbiology laboratory. 7. Support continuous improvement in the laboratory and identify gaps in the current QC processes related to microbiology laboratory and plan improvement/ implementation with the QC Manager. 8. Ensure all testing and associated activities are performed in accordance with GMP and strict industry compliance standards. 9. Manage the QC laboratory waste program in the microbiology laboratory and ensure that all QC generated waste are properly segregated and disposed. 10. Participate to equipment qualification, calibration and maintenance in the microbiology laboratory 11. Be responsible for all method validations in the microbiology laboratory 12. Provide support to QC Assistant Manager in the scope of realisation of the stability studies program of the company 13. Be familiar with Eudralex Vol IV and other related directives and regulations especially those related to QC work. 14. Manage sampling plans and retained sample management 15. Out of Specification (OOS) result investigations and trending 16. Participate in approval of in-process controls 17. Responsible for management of reference standards 18. Responsible for qualification of QC equipment in the microbiology laboratory 19. Participate in complaints analysis 20. Organize, manage and execute testing of validation samples in the microbiology laboratory 21. On request of QC Assistant Manager provides assistance in audits of contract labs 22. Participate in Annual Product Review (APR) data compilation 23. Participate and manage Statistical Process Control (SPC) / Statistical Quality Control (SQC) 24. Participate in the Environmental monitoring 25. On request of QC Assistant Manager, participate in Analytical Development either as part of QC or separate organizational unit (e.g. method development, method validation, specification generation, method transfer, new QC technologies Pharmacopoeia review, troubleshooting) 26. Participate inanalytical method transfers in the microbiology laboratory 27. The authorization of written procedures and other documents, including amendments related to QC testing in the microbiology laboratory 28. Responsible for QC microbiology laboratory premises hygiene. 29. Responsible for the retention of relevant records in the microbiology laboratory. 30. Responsible for the monitoring of compliance with the requirements of Good Manufacturing Practice in the microbiology laboratory 31. Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management 32. Any other duties assigned by the QC Assistant Manager Microbiology and/or QC Manager related to the pharmaceutical industry