Quality Compliance Specialist

Genveon İlaç Sanayi ve Ticaret A.Ş.

We are looking for a Quality Compliance Specialist that will be responsible from the following processes:

Main Responsibilities

To assure that the requirements related to process and product quality as well as compliance are fulfilled as stated in our company’s quality standards and Ministry of Health requirements and to assure that Quality Unit of site takes a position at the top of the company with regard to compliance, service quality and performance criteria.

To ensure that GMP requirements are completely and effectively implemented. 

Response to the Health Authorities regarding to the findings

Create CAPA plan and ensure to close accurately on time

Reporting Quality Key Performance Indicators to the Cocpit, WBR and MBR.

Manage Self-Inspections and walkthroughs

Lead implementation of Global Operation Procedure and Quality Manuel

Response to the Quality Alert Notification coming from Global Quality

Prepare annual Site Quality and Data Integrity Plans based on annual risk assessment

Minimum Requirements

Min. 5 year experience in Quality Assurance

Intermediate or Upper Intermediate English

Good knowledge of SAP, Trackwise, QMEX and Office Programs

Good at preparing risk assessment and Time Management.

Having a good level of Quality Mindset.