Job Description

Are you passionate about ensuring the safety and quality of pharmaceutical products? Do you have experience in quality assurance and control? We are looking for a dedicated Quality Specialist to join our team at Novo Nordisk Malaysia. If you are ready to make a difference and contribute to the overall compliance of our affiliates and distributors, read on and apply today for a life-changing career.About the department
Novo Nordisk (NN) has been globally recognized as the Best Place to Work, topping the ranks for two consecutive years in 2022 and 2023. It is an exciting time to join Novo Nordisk and be part of a dynamic company in an even more dynamic industry, helping us achieve our aspirations to establish a global presence in the industry.At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For over 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers and the opportunity to help improve the quality of life for millions of people around the world.The position
The Quality Assurance Specialist ensures overall Quality Management System (QMS) compliance for Novo Nordisk\'s Malaysia affiliate and its distributors, adhering to Novo Nordisk principles, internal requirements, and external laws and regulations.Key responsibilities:

• Support the Local Quality Responsible Person (LQRP) in quality assurance and control, defining activities, processes, and standards for service and product quality. Ensure compliance with internal and external quality requirements, maintaining high standards of safety, efficacy, and product quality, and collaborate with cross-functional teams to implement quality initiatives.
• Support the preparation and conduct of the Quality Management Review (QMR). Implement and monitor QMS training processes and metrics. Manage and monitor Deviations and Corrective and Preventive Actions (CAPAs). Oversee Change Requests to ensure timely management and closure. Coordinate product release, including temperature deviation reviews.
• Coordinate repackaging activities and approve batch documentation. Manage and approve product returns and destruction processes. Report customer complaints per internal and external requirements. Assist in handling potential recall situations. Ensure audit readiness and coordinate internal and external audits.
• Act as on-site QA for distributor/supplier audits, serving as Lead Auditor for external third-party audits within BASEA. Manage the document lifecycle process and periodic review monitoring, while also approving the implementation of relevant laws and quality requirements. Additionally, collaborate with BASEA affiliates and BA offices on quality operations.
• Participate in quality improvement projects, stay updated on industry trends and regulatory changes, provide training and support to local users on quality systems, and contribute to strategic quality planning and implementation.

Qualifications

• A degree in Medicine, Pharmaceutical Sciences, or a related science discipline. Relevant certifications or training in quality management are advantageous. Continuous professional development in quality and regulatory standards, along with knowledge of industry best practices and emerging trends. Understanding of global and local pharmaceutical regulations.
• 1-3 years in a quality role within the pharmaceuticals or medical device industry; broad knowledge of the pharmaceutical industry, preferably in a global context; experience in managing quality processes and cross-functional teams; proven track record in maintaining high standards of quality and compliance.
• Awareness of local or international quality and regulatory requirements; ability to ensure compliance with internal and external quality requirements.
• Strong quality mindset and attention to detail; excellent communication and stakeholder management skills; resilient and adaptable to changing environments; committed team player and strong individual contributor.
• Unquestionable ethics and integrity; commitment to maintaining high standards of safety, efficacy, and product quality.

Working at Novo NordiskAt Novo Nordisk, we don\xe2\x80\x99t wait for change. We drive it. We\xe2\x80\x99re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We encompass the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development to manufacturing, marketing, and sales \xe2\x80\x93 we\xe2\x80\x99re all working to move the needle on patient care.Contact
Upload your CV to our online career page (click on Apply and follow the instructions).Deadline
29 Jul 2024We 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\xe2\x80\x99re life changing.#LI-AMS1

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