Urgent
Quality Assurance Engineer
AGC株式会社
- TOEIC
- English Proficiency
- GMP
- QA
- Validation
- pharmaceutical regulations
- QC
- Bio-pharmaceutical
- Microbiology
- Biochemistry
- Manufacturer
- Overseas site
- Pharmaceutical application business
- Pharmaceutical related
-
Chiba
-
1,001 to 10,000
Company Info
AGC Corporation provides analysis technology related to products and applications for environmental and industrial purposes. We provide an environment where extensive product analysis technology can be developed, and knowledge and experience can be accumulated.Job Summary
Responsible for quality assurance business related to the production of bio-pharmaceuticals (raw materials), implementation and management of GMP operations, management of validation, and collaboration with manufacturers, and wide-ranging business such as inspection and response of pharmaceutical regulations, and experience in GMP operations and life sciences fields such as validation and analysis methods are required, and English proficiency is also required.Duties
【Quality Assurance Business related to the production of bio-pharmaceuticals】 ・Practical implementation of GMP ・Implementation and management of GMP operations (for example, change management, deviation handling, document management, validation, and inspection management, and supplier management) ・Management and implementation of validation of manufacturing ・Collaboration with manufacturers ・Investigation and response of pharmaceutical regulations, etc. ・Collaboration with manufacturers for quality-related communication (such as change and deviation communication, contract quality agreement, etc.) ・Application for new drug approval and some change applications, etc. ・Collaboration with manufacturers for inspection and response ・Integration of GMP systems with overseas affiliated companies, and collaboration with overseas sites ・Commonization of GMP systems with overseas sitesLogin to see all information about offers.
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