Location: The Netherlands, Amsterdam
If you are the person full of passion, energy, looking for innovative solutions for the patients and enjoying working in the TEAM of people sharing your inspiration and openness – this the position for YOU!
As Country Quality Manager - QP/RP you will assure that the product quality conforms with specifications and that production activity is compliant with Novartis quality policy and GxP requirements and you will be ensure that relevant documentation is up-to-date and archived correctly. Furthermore you will be responsible for the “state of the art” GxP know-how and future trends in the field of GxP.
Your key responsibilities:
• Ensure that all aspects of the handling, manufacturing and distribution of biopharmaceutical / pharmaceutical products are in compliance with the Novartis Quality Manual, the effective Quality Agreement that they meet relevant GxP regulatory requirements and are conducted according to local SOPs.
• Review and archive batch documentation, conduct self-inspections, and monitor corrective actions
• Conduct GxP monitoring, investigate noncompliance, and manage critical quality issues
• Escalate issues per Novartis escalation policy and initiate market actions if required
• Assess quality trends and drive continuous improvement for processes and product quality
• Maintain contacts with regulatory authorities and stay updated on GxP regulations
• Support product launches in collaboration with partners and development organizations
• Ensure drug products are released in accordance with specifications and regulations
• Maintain coordinated contact with regulatory certified QP and RP