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.

• 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.

• 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

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

• English.