Quality Operations Specialist

Sandoz Grup San. Ve Tic. A.Ş.

As Novartis Technical Operations, we are looking for a Quality Operations Specialist that will be responsible from the following processes:

To ensure that GMP requirements defined by MOH, Novartis / Sandoz Quality Manual are completely and effectively implemented

Establish Quality Culture and awareness

To comply with Novartis Data Integrity policy & rules To comply with Novartis Privacy declaration & procedures To inform related department in case security events & violation Keep the confidentiality and originality of all documents

Comply with local regulations related to HSE and Sandoz policies Contribute to saving projects in order to reduce costs, and help to complete Quality Assurance related projects.

Providing active, real time periodically GMP checks and compliance enforcement during production operations. During production operations, making spontaneous IPC tests Implement all aspects of Quality, Occupational Health, Wellbeing, Safety, Environment, Emergency Management and Business Continuity according to Novartis Policies / Guide Lines / Operational Procedures and Legal Regulations for responsible area / unit / operations and contractor operations.

To Deputate QA in production and use approval rights for all type of GxP document, system and batch release operations when it’s needed.

To publish weekly release plan.To report KPI datas as weekly and monthly related to QA.

To be SAP superuser in Gebze 2 Quality Operations department, to open role requests and to provide training for end-users and also in case of a problem or need for an enhancement, to ensure correct communication between end-users and SAP consultants and to follow up the incident/enhancement Handling of Customer Complaints and Deviations, BR Review and Batch Release, QA in PU, Audits. Revision of existing SOPs and/or generation of new ones based on the related QM/QD/GOP.

To give refreshing GMP trainings whenever required.

To support the implementation of GMP training program.

To approve SOP, MFC and MBR on behalf of Quality Operations Manager if necessary.

To control OPV documents and process validation documents.

Supporting the evaluation and completion of change control actions. Tracking of CAPAs.