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Quality Assurance Officer
hace 2 semanas
**Summary**:
The QA Officer guarantees the quality oversight over the entire working time of the facility for all the GMP activities on going.
**About the Role**:
**Major accountabilities**:
- 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
**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.
Division
Operations
Business Unit
Innovative Medicines
Location
Spain
Site
Zaragoza
Company / Legal Entity
ES45 (FCRS = ES045) AAA Ibérica S.L.U.
Functional Area
Quality
Job Type
Full time
Employment Type
Regular
Shift Work
No
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
