Quality Operations Specialist

Sandoz İlaç 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 assure that the requirements related to process and product quality as well as compliance are fulfilled as stated in Sandoz quality standards and Ministry of Health requirements and to assure that Quality Unit of Sandoz Gebze 1 takes a position at the top of Sandoz Group companies with regard to compliance, service quality and performance criteria.

• To ensure that GMP requirements defined by MOH, Novartis / Sandoz Quality Manual arecompletely and effectively implemented. 

• Daily review of event logs created in MES to make sure that all discrepancies and deviations were properly identified and investigated, then acknowledge of these events.
• To make the batch record review and batch release process completely and on time before dispatch, usage or sales decision of the products.

• To ensure that the storage of the reserve samples are done on time and without defect and to keep the layout plant of the reserve samples achieve updated.

• To make a usage decision of the products (local and export, bulk and final products) and returned products and dispatch decision of the export products to the other countries and enter to the SAP system after evaluation of the batch  records with batch release authorization which is delegated by QP.

• To enter the destruction or release decision of the returned and customer complaint products to the SAP system.

• Contribute to do the activities about filing of recall and event reports where needed and to take or provide the related distribution lists.

• To follow up the back order reports daily and to ensure that the products are sent to sales on time.

• Thorough and timely  investigation of  quality deviations, determination of root cause in coordination with related department

• Review of prepared deviations reports

• Assignment and follow-up of corrective and preventive actions

• Archiving of deviation reports and keeping deviation list updated
• Trend analysis of the deviations and reporting on a quarterly and annual basis
• Tracking of CAPAs related to deviations , complaints, self inspection and walkthroughs
• Checking MBRs if they are compliant to regulatory files. Also checking if actions of CAPA and Change Requests which requires MBR revisions are done correctly in MBR.

• During approval stage of export products Master Batch Records, to contact with related countries and ensure receiving approvals for Master Batch Records.

• Checking BOMs if they are compliant to regulatory files.

• Support Complaint Investigation when needed.