Résumé
Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
About the role:
We are seeking for Quality Assurance Support, as part of the Canadian Country Quality Team, you are responsible to support the operational activities for marketed products in Canada and ensure that all aspects of the operation comply with GxP, legal and regulatory requirements.
This role will work directly with the Canadian Country Quality team and reports to the Quality Assurance Manager .
About the Role
Key responsibilities:
- Ensure all quality-relevant processes within Country Organization are compliant and that non-compliance is appropriately 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, and to meet business expectations.
- Prevent quality or regulatory non-compliance issues which could lead to product stock-out or withdrawal, product approval delays or which would negatively impact the financial performance of the company, as well as the company reputation.
- Ensure the development of Quality Culture with high awareness on data integrity and close collaboration with business partners, and ensure a state of the art Country Quality Organization is in place to best support overall business strategy.
- Establish effective Quality oversight and ensure Quality Plan is implemented, establish regular review and assessment of KQIs at the Executive Committees.
- Implement applicable Quality Standards and effective CAPA processes and ensure compliance with escalation processes in the Organization.
- 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 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
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
