QA Engineer I

Job title: QA Engineer I

Company: Novo Nordisk

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Accept ClosePress Tab to Move to Skip to Content LinkSearch by KeywordSearch by LocationLoading…Category×Select how often (in days) to receive an alert:×Select how often (in days) to receive an alert:QA Engineer ICategory: QualityLocation:Tianjin, Tianjin, CNAre you motivated by driving innovation for the life-changing benefit of patients? Are you ready to help transform the treatment paradigm for a broad range of chronic diseases that currently rely on injection-based therapies? Then this is your moment. Apply now and join Novo Nordisk. Together we can create life-changing innovation. Together we can make it happen.The positionThe tasks for this position holder are primarily related to QA for Prefilled assembly department but may be extended to other insulin operation QA responsible areas when line management judges the position-holder has necessary knowledge and experience. related to quality assurance within the department, but the tasks of this position may be expanded to other areas of insulin operational quality assurance responsibility when line management determines that the individual in this position possesses the necessary knowledge and experience.

• Provide quality and compliance related input and make decisions on quality and compliance related issues. Give suggestions and opinions on quality and compliance related issues and decide how to deal with them.
• Perform QA presence for responsible area and handling relevant issues. Perform quality assurance supervision and handle relevant issues in the area of ​​responsibility.
• Establish SOPs for quality related processes and procedures where relevant

Establish SOPs for quality-related processes and operating procedures. * Provide training to employees within and outside of the quality assurance department. Provide quality-related training to employees.

• Handle and answer internal and external (authority) audits and regulatory affair inquiries. Handle and answer internal and external (authority) audits and regulatory affair inquiries.
• Review Batch production record Review production batch record
• Prepare documentation for product registration submission. Prepare documentation for product registration submission.

Review and approve operational documents requiring QA approval, including but not limited to: Review and approve all operational documents requiring QA approval, including but not limited to:

• Standard operating procedure (SOP) Standard operating procedure
• Batch production record (BPR) batch production record
• Deviations (DV)
• Customer complain (CC) Customer complaint
• Change requests Change(CR)
• Quality case quality activity plan
• Preventative maintenance plans Preventive maintenance plans (PMP)
• Calibration specification sheets Calibration instructions
• logbook log

Qualifications

• Bachelor’s degree or above in pharmaceutics, Chemical industry, engineering or other relevant.

Bachelor degree or above in pharmacy, chemical engineering, engineering or other related majors.

• Fluent in written and spoken English

Good English writing and communication skills

• Minimum 5 years Working experience in pharmaceutical industry, including at least 1 year of quality assurance or pharmaceutical product.

At least 5 years of experience in the pharmaceutical industry, including at least 1 year of experience in quality assurance or pharmaceutical products.

• Ability to motivate and lead process improvements for responsible area. Ability to motivate and lead process improvements for responsible area.
• Good knowledge on regulatory requirements and expectations from NMPA and EU. 熟悉

and EU regulatory requirements* Ability to work effectively in cross-organizational networksWorking at Novo NordiskAt Novo Nordisk we recognise 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 the communities we operate in.We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We are happy to discuss flexible working, depending on the role and subject to business needs.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.

Expected salary:

Location: Tianjin

Job date: Wed, 27 Mar 2024 04:20:00 GMT

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