Responsibilities:
- Implement and promote GQP operations (Release control, manufacturing site control, preparation of necessary documents, quality information control, change control, quality agreement, etc.)
- Establish a system including record management in anticipation of future renewal surveys of the marketing business
- Collaboration with Global QA and Supply Chain (Deployment of Genmab Global policy to Japan, communication of necessary matters in Japan to Global, establishment of better SOPs in collaboration with Global)
- Operations as MAH QA function that handles antibody drugs
Organization and Position:
- Genmab has a CMC in the Regulatory Affairs (RA CMC) and CMC in charge of supply chain and technology-related operations. QA and CMC are independent in the Global organization but integrated in Genmab KK (Japan)
- The position is GMP QA and includes GMP but GMP operations are not performed, though overseeing manufacturing sites as GQP of MAH
- Our company does not have own manufacturing plant, all manufacturing is performed by CMO in Japan and overseas
- Our development is focused on antibody products
Essential Experiences and Skills:
- Broad knowledge and experience of GQP (operations in contact with MAH QA on the manufacturing site side are also acceptable)
- QA experience in GQP or GMP (3 years or more)
- Business English (email, document check, etc.)
Desired Experiences and Skills:
- Actions relating to GMP Compliance Inspection, Foreign manufacturers accreditation (FMA) and maintenance of business license (MAH, Manufacturing license, etc.)
- Business / communication with Global functions, manufacturing sites, etc.
- Experiences to use Software generally used as MAH QA (Document management system, Quality information registration systems, etc.)
- Valid working visa or permanent residency in Japan.
- Native level Japanese in verbal, reading, & writing.
Company Culture: Genmab values teamwork, inclusivity, and open communication. We promote diversity and foster an environment where employees from different backgrounds can work together to achieve our goal of improving cancer treatment.
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Tokyo Genmabジェンマブは、革新的で独自性のある抗体治療薬の開発に注力し、患者さんの人生をより豊かにすることを目的としています。 · JD for QA/CMC GMP QA position · Activity · As MAH QA, implement and promote GQP operations (Release control, manufacturing site control, preparation of necessary documents, quality information control, change control, qu ...
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Tokyo Genmabジェンマブは、革新的で独自性のある抗体治療薬の開発に注力し、患者さんの人生をより豊かにすることを目的としています。 · The Role & Department · As MAH QA, implement and promote GQP operations (Release control, manufacturing site control, preparation of necessary documents, quality information control, change control, quality agreement, et ...
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