This listing was posted on Novo Nordisk.
Drug Quality Inspector Specialist
Location:
Shanghai
Description:
Quality inspection and release Strictly implement the product quality management system and operation rules formulated by the enterprise, and standardize the quality inspection work. Complete the purchased product inspection and returned product according to GSP standards, warehousing documents, and product acceptance procedures. Acceptance shall be carried out in strict accordance with the prescribed standards, acceptance methods and sampling principles, and shall be completed within the prescribed place and time limit. Indicate the acceptance conclusion in the system for the inspected goods, make a good record of product quality acceptance, and keep it for future reference in accordance with regulations. The quality changes found in the acceptance shall be timely fed back to the quality management personnel. Information is analyzed, processed, and summarized. Cooperate with the department to make good quality file. Responsible for the comprehensive inspection and acceptance of the traceable varieties of drugs/device purchased and returned by sales. Release the product for marketing according local GSP regulation and NN Standards. Quality evaluation for drug product in China marketing. Temperature data review for incoming product and return product. COA check during incoming inspection. Indicate the acceptance conclusion in the system for the inspected goods, make a good record of product quality acceptance, and keep it for future reference in accordance with regulations. Information is analyzed, processed, and summarized. Cooperate with the department to make good quality file. Quality assurance related documentation archive and management. Be responsible for the investigation, handling and reporting of quality complaints, deviation, and quality incidents. Release the product for RDC according to RDC inspection records, temperature data and related supporting documents. Evaluate any temperature excursion based on NN PSR. Be responsible for the reporting of fake and inferior drugs. Other task assigned by line manager. COA check, translation, and management. COA check and translation for imported product according to registration documentation. Imported product check according to registration documentation and ensure compliance China regulation. COA collection and archiving, make sure the traceability. Warehouse quality document management. Collect quality information, accurately and timely transfer and feedback, and collect all kinds of quality inquire. Responsible for warehouse quality related documentation archiving, including DN, inspection related records, temperature data for product inspection or evaluation, etc. Develop the release list to make sure the traceability of product, including order information, batch information, temperature data log, temperature excursion registration, etc. College degree or above in pharmacy, biology, chemistry, medicine or other related area. Familiar with local GDP (GSP)/GMP. Above 3 years quality experience in GMP or GDP (GSP) area. Above 1 years quality experience for product inspection and release. Good English skill at reading, writing, listening, and speaking. Good communication skills of both scientific and non-scientific information. Professional knowledge in local regulations. Problem solving ability and skills. Ability to face challenge and self-learning. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
Company:
Novo Nordisk
Posted:
May 17 on Novo Nordisk
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