The QA Officer guarantees quality oversight throughout the facility's operations for all ongoing GMP activities.
About the Role
Major accountabilities:
* Supervise the hygiene conditions of the premises under management.
* Assist in ensuring the validation/qualification status of the production site, equipment, personnel training, and quality documentation management.
* Responsible for provisional batch release for shipment.
* Work in shifts with other QA officers to oversee production and quality control activities.
* Archive and support site GMP documentation management, review batch records, and ensure timely closure of batches.
* Maintain the local quality system according to GMPs and corporate guidelines, ensuring compliance with GMPs and health authority requirements at the local level.
* Support the QP in preparing batch release documents.
* Collaborate on drafting site GMP documentation and preparing/printing batch documentation.
* Assist during external audits by authorities and corporate audits.
* Contribute to data compilation for Product Reviews, oversee investigations, and monitor the implementation of corrective actions.
* Participate in self-inspections as per the annual plan and in external audits.
* Ensure appropriate quality oversight during GMP activities, verifying compliance with manufacturing, quality control, distribution, and quality processes.
Education: Scientific degree in Pharmacy, Chemistry, or Biology.
Experience: 1+ years in a Quality department.
Skills: Strong awareness of quality issues, good organizational skills, attention to detail, solid knowledge of GMP and basic regulatory requirements, fluent in English (verbal and written).
Why Novartis? Our purpose is to reimagine medicine to improve and extend people's lives. Join us and be part of this mission! Learn more: https://www.novartis.com/about/strategy/people-and-culture
Benefits and rewards: Discover how we support your growth: https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity and Inclusion: We strive to build an inclusive, diverse work environment reflecting the communities we serve.
Join our Novartis Network: Stay connected and learn about opportunities: https://talentnetwork.novartis.com/network
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