Specialist – Quality Operations

Quality Assurance Manager

Manages Quality aspects and projects within area of responsibility. Ensures and supports overall GxP conformity and compliance with the Novartis Quality Management Systems.

Key Responsibilities:

• Oversight of all production and testing activities, ensures compliance with cGxP, including data integrity and eCompliance.
• Support exception investigations.
• Review and approval of production, QC, and AS and T records.
• MBR review.
• Support OpEx improvement projects.
• Qualified Person – Executes batch release in compliance with registration.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.
• Distribution of marketing samples (where applicable).

Essential Requirements:

• 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.

Desirable Requirements:

• Functional Breadth.
• QC/QA in pharmaceutical ind./biotech with environmental monitoring &.
• Collaborating across boundaries.
• Cleanliness zones.

Skills:

• Continuous Learning.
• Dealing With Ambiguity.
• GMP Procedures.
• QA (Quality Assurance).
• Quality Control (QC) Testing.
• Quality Standards.
• Self Awareness.
• Technological Expertise.
• Technological Intelligence.

Languages:

• English.

Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us!

Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Skills Desired: Continued Learning, Dealing With Ambiguity, GMP Procedures, QA (Quality Assurance), Quality Control (QC) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence.