Job Description Summary
The QA Officer guarantees the quality oversight over the entire working time of the facility for all the GMP activities on going.
Job Description
Major accountabilities:
- Supervise the general conditions of hygiene of the premises subject to its management
- Contribute in assuring the validation/qualification status of the production site, equipment, training of personnel and management of quality documentation
- Responsible for the provisional release for the shipment of batches
- Work in shift with other QA officers to oversight the production and quality control activities.
- Archiving and support in managing the site GMP documentation, review of batch records and assure the timely closure of the manufactured batches.
- Contribute in maintaining the local quality system as per GMPs and corporate guidelines and in assuring the respect of the GMPs and Health Authorities requirements at local level
- Support the QP in the preparation of batches release documents
- Collaborate in redaction of site GMP documentation and preparation and printing of batch documentation
- Support during the external audits by the authorities and corporate audits
- Collaboration in data compilation of Product Reviews, oversight on investigations and monitoring of resulting actions are checked and approved.
- Participate to the self-inspections as per approved annual plan and to the external audits
- Be responsible for the appropriate level of quality oversight during the GMP activities of the facility verifying they are executed according to the applicable standards in manufacturing, quality control, distribution and quality processes.
Minimum Requirements:
- Education: Scientific degree in Pharmacy, Chemistry or Biology
- 1+ years of experience in a Quality department.
- Strong affinity with and awareness of Quality issues
- Good organizational skills including attention to details
- Solid knowledge of quality system (GMP) and basic knowledge of regulatory requirements
- Fluent English verbally and in writing
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.
