Sr.Quality Maintenance specialist

• Strictly implement the commodity maintenance management system and in-store maintenance procedures formulated by the company, and be specifically responsible for the maintenance and quality inspection of goods in the warehouse under the technical guidance of the quality department.
• Instruct and supervise warehouse keepers to properly store and operate commodities.
• Check and improve the storage conditions, protective measures and hygienic environment of the goods in the warehouse.
• Check the packaging or appearance of goods in stock on a quarterly basis according to the maintenance plan; Inspect key maintenance varieties such as near-expiry period, unstable quality, recent quality problems, long storage time and refrigerated commodities on a monthly basis, and make maintenance inspection records. Establish and improve commodity maintenance files.
• According to the characteristics of commodities, adopt correct methods for scientific conservation.
• Goods with quality problems found during maintenance inspection shall be locked in the computer system in time and informed to the quality department for treatment.
• Summarize and analyze product maintenance information.
• When the temperature and humidity of the commodity storage environment exceeds the specified range, notify the relevant departments to take effective measures to control the temperature and humidity in time to prevent the impact of excessive temperature and humidity on the quality of the commodity, and make sure the deviation opened by related department timely.
• Responsible for generating and monitoring of VMP for NNSH GSP, maintaining and improving according to local GDP (GSP)/GMP and Global Standards.
• Developing validation procedures.
• Organize and coordinate validation related activities according to project plan.
• Responsible for preparing and reviewing qualification protocols, reports.
• Perform the execution of qualification, validation.
• Complete all validation and qualification related documents and SOPs on a timely manner.
• Work with project team and support all activities of facility’s design, commissioning and qualification, review related documents.
• Validation trainings.
• Guild warehouse team to establish equipment maintenance plan.
• Review and approve equipment maintenance plan and record.
• Perform the regularly equipment performance review together with warehouse team.
• Establish and maintain product quality archive.
• Responsible for Product Quality Maintenance, create the plan and execution.
• Perform the quality related operation in ERP system, MPA system and other electronic management system.
• Responsible for quality operations in warehouse management, transportation and distributor channel.
• Set up the pest control strategy, guild the implementation.
• Responsible for the investigation, handling and report of quality accident (deviation).
• Deviation QA in NovoGlow.
• Support distributor qualification and audit.
• Other duties as assigned by supervisor.

• College degree or above in pharmacy, biology, chemistry, medicine or other related area.
• Familiar with local GDP (GSP)/GMP.
• Above 5 years quality experience in GMP or GDP (GSP) area.
• Above 3 years validation experience in GxP area.
• 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.