Quality Assurance Support

Summary

About the role: We are seeking for Quality Assurance Support, as part of the Canadian Country Quality Team. You will support the operational activities for marketed products in Canada and ensure compliance with GxP, legal, and regulatory requirements.

Key responsibilities:

• Ensure all quality-relevant processes within Country Organization are compliant and that non-compliance is addressed via corrective and preventive actions (CAPA) and/or escalation of issues.
• Ensure quality oversight and governance to ensure proactive compliance with Company and Health Authority GxP requirements.
• Prevent quality or regulatory non-compliance issues that could lead to product stock-out or withdrawal, product approval delays, or negatively impact financial performance and company reputation.
• Develop a Quality Culture with high awareness on data integrity and collaboration with business partners.
• Establish effective Quality oversight and implement the Quality Plan, regularly reviewing KQIs at the Executive Committees.
• Implement applicable Quality Standards and effective CAPA processes, ensuring compliance with escalation processes.
• Ensure that relevant SOPs are aligned to HA regulatory requirements.
• Assist the Quality Assurance team with other GMP activities as required (i.e. recalls, audits, inspections, stability, APQR, complaints, batch release and deviations).

What you’ll bring to the role:

Essential:

• Bachelor in Science or equivalent
• Sound knowledge of GxP
• Ability to communicate and write reports clearly
• Knowledge of Pharmaceutical operations regarding manufacturing processes and chemical formulations (2-3 years)
• Initiative, self-motivation, and superior organizational and time management skills
• Able to prioritize, be autonomous and proactive

Desirable:

• Master in Pharmaceutical Sciences

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people. Collaborating, supporting, and inspiring each other to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

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