Company OverviewLeading Global Animal Health Company
Job DescriptionJob Summary
1 Ensure Quality of our Animal Health Products (Biologicals and Pharmaceuticals including Regenerative products, Medical Devices and other animal health products which our company distributes to Japan in accordance with the Japanese & global regulations and our company’s GxP procedures.
2 Ensure GxP activities of local Third Parties (e.g. CMO, Manufactures for visual inspections, packaging, storage, Laboratories for Quality Control) to comply with the Japanese & global regulations as well as Contracts and Quality Agreements.
Perform Quality Assurance activities such as Releasing products, dealing with Technical Product complaints, Deviations, Events, Audits and Change Controls in accordance with local procedures of our company’s GQP, GMP and Wholesaler procedures
1 Take actions as Qualified person in the GQP/GVP organization
a. Lead necessary actions on Quality including Market actions (e.g. Recall)
2 Responsible for releasing commercial products including National Assay process
a. Release products in accordance with our company’s business intelligence system.
3 Ensure handling of Technical Product Complaints (TPC), Deviation, Event, Audits and Changes
a. Deal with actions in accordance with our company’s business intelligence system.
4 Assure Third Party activities based on Quality Assurance Agreement (QAA) and contracts
a. Monitor their activities such as visual inspections and packaging to ensure they comply with QAAs and contracts
5 Creation and update of our company’s GxP procedures
a. Create and maintain procedures to comply with Japanese regulations and BI regulations
6 Take actions to improve Quality Global Quality team and/or Production sites to improve Quality
a. Closely communicate with Global Quality, Production sites and Internal divisions, and execute actions
7 Provide knowledge as Qualified person to our company’s organization
a. Introduce Quality requirements in the our company’s organization
8 Provide ideas on strategic management of QA in our company
a. Proceed to maximize QA capable with strategic mindset.
• At least 3 years Quality Assurance, Quality Control, Regulatory Affairs, and/or R&D development experiences in Animal Health and/or Human Health Industries
• Knowledge of Manufacturing process, Quality Control and Regulations such as National Assay
• Ability to evaluate Quality impact
• Excellent oral and written communication skills in Japanese and English
Additional Job InformationInterested?
Please reach out to firstname.lastname@example.org for more details.