Quality Compliance Specialist İş İlanı

QUALIFICATIONS AND JOB DESCRIPTION

Jenerik dünyaya inovasyon katan Türkiye’nin genç, dinamik, yenilikçi ve başarı odaklı sağlık şirketi;GENVEON Gebze Plastikçiler Organize Sanayi bölgesinde yer alan İlaç Üretim Tesisimizde görevlendirilmek üzere Kalite Uyum Uzmanı arıyor!

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 and trace CAPA plan and ensure to close accurately on time
• Reporting Quality Key Performance Indicators to the Cockpit, WBR and MBR.
• Manage Self-Inspections and walkthroughs
• Preparation of Annual Product Quality Review
• Prepare annual Site Quality and Data Integrity Plans based on annual site Quality Risk Assessment

Minimum Requirements

• Bachelor’s degree in chemistry, pharmacy or related departments
• Min. 5 year experience in Quality Assurance in Pharmaceutical Industry
• Intermediate or Upper Intermediate English
• Good knowledge of SAP, QMEX and Office Programs
• Good at preparing risk assessment and Time Management.
• Having a good level of Quality Mindset.
• Having a good level of Quality mindset. (Having global company experience is a plus)

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