Istanbul, Istanbul, Türkiye
-Review and release imported and 3rd party product batch records. -Attend escalation call, prepare escalation report, and follow escalation process. -Follow/implement local regulations and GMP and GDP requirements. -Take a role in self-inspection and external inspection as an auditor. -Follow up CAPAs that identified during the quality/ GMP inspection, which performed, by Ministry of Health / other sites/ authorities results and ensure for the completion of relevant actions. -Prepare site master file through coordination of the related departments -Manage deviation and complaint processes and follow up the CAPAs -Review annual product quality review report. -Evaluate and report returned goods. -Prepare and revise related SOPs. -Oversee warehouse quality operations. -To contribute saving projects in order to reduce costs. -Takes part in product launches in terms of quality relevant actions.
- Managing a team of 21 technicians in production - Lead Operational Excellence and Productivity projects - Coordinate projects together with QA, QC, Engineering and Purchasing
- Attending to the audits as an auditor, preparing the audit reports and follow up of the actions - Review and release production batch records. - Investigate production deviation and determination of root cause in coordination with related department. - Assignment and follow-up of corrective and preventive actions (CAPAs). - Preparation of APQR (Annual Product Quality Review). - Review and approve Master Batch Record. - Preparation of escalation report and following the escalation process. - Investigation, evaluation, completion and reporting of internal and external complaints. - Review the qualification documentation of Production equipment, Utilities (BMS and Purified Water System), Analytical Equipment and IT Systems. - Responsible of computerized system validation process. - Development and implementation of the Local Data Integrity plan according to global / divisional Data Integrity plan.
-Takes part in Novartis Coartem Project as a Validation Consultant of production equipment qualification and HVAC system. -Prepares DQ, IQ, OQ and PQ protocols and execute the qualification activities of production equipment and HVAC system.
- Takes part in the validation of the computerized systems in the factory - Takes part in process validation; in charge of document preparation and coordination of the QC analyses - Takes part in cleaning validation; in charge of document preparation and coordination of the QC analyses - Is in charge of the documentation of change control documents and related correspondence with the Regulatory Dept. - Prepared product master files through coordination of the related departments - Prepared pilot production area site master file through coordination of the related departments - Reported and followed up action plan for out-of-specification results and deviations - Was instrumental in the preparation of registration applications to the Ministry of Health: documented chemical, pharmaceutical and biological aspects of new medicinal products in light of the international guidelines (ICH) - Takes part in the SAP project as a QM user