Country Quality Lead & Qualified Person

Novartis AG

Ataşehir

On-site

TRY 350,000 - 550,000

Full time

3 days ago

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Job summary

Novartis AG Türkiye is seeking a Country Quality Manager & Qualified Person to lead the local Quality Management System, ensuring regulatory compliance and adherence to Novartis Quality Manual for Farmanova products. You will perform batch release checks as the Qualified Person and drive CAPAs, audits and vendor management in collaboration with Health Authorities and global functions.

The role requires a University degree in Pharmacy/Engineering/Chemistry, advanced English, and at least 6

Qualifications

Advanced written and verbal communication in English.
At least 6 years of Quality experience in pharmaceutical industry.
At least 2 years at a pharmaceutical manufacturing site in Quality Control/Quality Assurance/Manufacturing Quality.
Strong knowledge of cGMP, GxP and pharmaceutical distribution processes.

Responsibilities

Manage local Quality Management System to comply with regulatory requirements and Novartis policies.
Ensure timely updates to GMP/GDP/barcode requirements for human medicinal products.
Fulfil Qualified Person duties for Farmanova, including batch release checks.
Perform release activities for supporting clinical products.
Approve artwork changes for Farmanova products.
Collaborate with Country functions to ensure efficient operation of the Country Quality System.
Maintain communication with Health Authorities and the Country organisation; track and close commitments.