摘要
About the Role
We offer fixed-term contract of 1 year.
Open Positions: 2
Quality Assurance Officer
Major Accountabilities:
- Supervise GMP activities in the shopfloor as to ensure they are carried out in accordance with GMP standards.
- Guarantee the correct document lifecycle management (paper and electronic system).
- Support the QP in the preparation of batch release documents as well as in the batch record closure.
- Support the release for shipment under quarantine process.
- Support the Artwork management process.
- Update the lists of documents related to the Quality Management System based on the indications of the reference SOPs.
- Management of Deviations, CAPA, change controls as required.
- Support the Self-Inspections as per approved annual plan.
Minimum Requirements:
- 1+ 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
- Availability to Work in a shift pattern including night shifts
- Fluent English and Spanish, written and spoken.
Quality Assurance Specialist
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.
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
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
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.
