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Date:  Apr 7, 2025
Location: 

Hung Hom, HK

Job Type:  Long-term/regular

 APAC Quality Assurance Specialist M/F (29976)

 

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.

 

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.

 

Achieve, Cooperate, Care and Innovate are the values ​​that we share and practice on a daily basis.

 

Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.

 

For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube

 

Serving as the Quality Contact Point for internal stakeholders and external partners for local and APAC, this position will ensure effective operational and quality compliance across the local and APAC repackaging and distribution network.

 

 

Main Responsibilities

  • Support the APAC QA Manager with quality assurance functions, including the handling of change controls, product complaints, deviation and CAPA, etc.
  • Ensure all work carried out in distribution and packaging is in compliance with the required standards conforming to company, cGxP, SOPs.
  • Ensure quality management system is in place so that warehouse is operated in compliance with cGDP 
  • Coordinate with warehouse operators, secondary packagers, third party suppliers and various stakeholders to ensure the logistics and packaging operations meet the quality requirements.
  • Conduct Operation of SAP (ERP system) Quality function as per procedures.
  • Support the management of product quality complaints and distribution complaints, and track complaint responses in a timely manner
  • Monitor Quality goals and metrics.
  • Assess and monitor contractors’ quality and performance.
  • Support internal & external audits.
  • Ensure that procedures are in line with Global Policies & Guidelines and current regulatory requirements.
  • Organize effective and efficient record archiving.
  • Develop, implement and maintain quality management system.
  • Review and create SOP, GXP documents and records
  • Deliver trainings.
  • Support and contribute continuous improvement initiatives and quality related projects
  • Lead and be responsible for quality related tasks and projects as appointed
  • Responsible for the coordination with affiliates to ensure GXP and regulatory requirements are fulfilled

 

 

Requirements

  • Bachelor’s degree in science or related fields
  • At least 3 years working experience in QA or RA
  • Excellent communication and presentation skills in Chinese (Cantonese &Mandarin) & English
  • Detail-minded, careful planning to achieve accurate and timely results
  • Ability to work independently
  • Experience with SOP and QMS development and implementation
  • SAP experiences will be an advantage

 

Reason to join US

Much more than a Competitive salary,


We offer continued personal development. When you join Guerbet, you :

  • Are choosing a global leader with recognized expertise in diagnostic and interventional imaging, 
  • Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient’s life all over the world,
  • Are joining a company where we value diversity of talents coming from various horizon.

 

We # Innovate # Cooperate # Care #Achieve at Guerbet. 

 

Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.

 

Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to careers@guerbet.com or you can also call this number +19843443717

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