Quality Operations Coordinator

Summary

Responsible for managing quality aspects within area of responsibility and to ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements and the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures

About the Role

Major accountabilities:

• Ensure production processes are performed in compliance with GMP rules
• Control batch records and release batches timely in order not to interrupt shipment program
• Perform investigation, evaluation and reporting of complaints and deviations
• Control and complete distribution of documents according to procedures
• Ensure that the risk assessment related to Quality Assurance are done.
• Follow up with the Quality system/GMP audit results of the Health Authorities and Novartis Companies
• Contribute to the cost effectiveness and development projects concerning the Quality Assurance Department.
• Ensure that all issue related to the local and Novartis HSE&BC regulations are handled accordingly.

Key performance indicators:

• On-time and GMP-compliant release of dosage forms -No Complaints about inspections by authorities in your own area of responsibility without these being noticed and communicated beforehand.
• Successfully Support continuous improvement Projects -Executes batch release in compliance with registration.

Minimum Requirements:

• University degree in Pharmaceuticals, Chemical Engineering or Chemistry
• Minimum 5 years of experience in a similar position at a multinational pharmaceutical company
• Extensive knowledge of GMP
• Preferably SAP knowledge
• Excellent communication skills in English
• Team working and customer-oriented mindset
• Ability to work in a fast-paced changing environment
• Detail-oriented, willing to work in a challenging environment

Skills:

• Continuous Learning.
• Managing Complexity.
• Employee Performance Evaluations.
• GMP Procedures.
• QA (Quality Assurance).
• Technological Expertise & Intelligence.

Languages :

• English.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

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Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Division
Operations

Business Unit
Innovative Medicines

Location
Türkiye

Site
İstanbul Kurtköy

Company / Legal Entity
TR01 (FCRS = TR001) Novartis Sağlık, Gıda ve Tarım Ürünleri San. Ve Tic. A.Ş.

Functional Area
Quality

Job Type
Full time

Employment Type
Regular

Shift Work
No