Job Description Summary
The Quality Assurance Officer / Specialist supports all the activities GMP related (operational and strategic), in order to guarantee the compliance with the regulatory requirements, quality standards and SOP in use, guaranteeing the quality oversight over the entire working time of the facility for all the GMP activities on going.
Job Description
We offer fixed-term contract of 1 year.
Open Positions: 2
Major Accountabilities:
- Support the the site program for ongoing inspection readiness in conjunction with the quality leadership team, including the site self-inspection program.
- Oversee and contribute to the timely completion of audit/inspection responses and reports, CAPA commitments, and internal/external communications with Health Authorities.
- Support the site level Quality Management Review (QMR) program including monitoring and reporting key performance indicators.
- Support Deviation,CAPA, OOX Management
- Support the following site QMS programs: Annual Product Quality Review (APQR), Compliance Alerts, Escalations, , Health Authority Notifications, Exceptions Handling, Document Control, Training, Data Integrity, and Novartis Global document assessment
- Ensure site program compliance with the legal requirements of the local Health Authorities and the Novartis audit/inspections quality systems.
- Lead/Support both site and global Change Controls and Change Review Boards to ensure consistent application of Compliance requirements and standards.
Minimum Requirements:
- 2+ years of experience in a Quality department
- Good organizational skills including attention to details
- Solid knowledge of quality system (GMP) and basic knowledge of regulatory requirements
- Fluent English and Spanish, written and spoken
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! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
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
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
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What We Do
Novartis is an innovative medicines company. Every day, working to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.
