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Guerbet is a leader in medical imaging worldwide, offering a wide range of pharmaceutical products, medical devices, digital and AI solutions for diagnostic and interventional imaging, to improve the diagnosis and treatment of patients.

A pioneer since more than 90 years in the field of contrast media, Guerbet is continuously innovating with 9% of revenue dedicated to Research & Development and four centers in France, Israel and the United States.

Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated €817 million in revenue in 2019 with a global workforce of over 2,800 employees.

Achieve, Cooperate, Care and Innovate are the values that Guerbet's employees share and practice every day. Working at Guerbet means playing a unique part in the future of medical imaging. Passionate about its business, the company strive day in, day out to combine performance, quality and sustainable development.

For more information about Guerbet, please go to www.guerbet.com  and follow Guerbet on Twitter @GuerbetGroup

 

QA Specialist

Guerbet is a leader in the medical imaging field offering health professionals innovative and effective contrast agents, medical devices and innovative solutions indispensable to diagnostic and interventional imaging to improve patients' prognosis for all major diseases and quality of life. 

Working at Guerbet means joining a human-scale company that aims to become a new global leader in Medical Imaging. 

 

Achieve, Cooperate, Care and Innovate are the values that we share and practice every day.

 

A vacancy now exists for the role of QA Specialist reporting to the Quality Manager. This is a Full Time-Permanent position, and the purpose of this role is to work within a cross functional environment to foster an ethos and culture of cGMP & Quality awareness.

Roles and Responsibilities

 

Principle Accountabilities include but are not limited to:                                                                            

  • Leading site cross-functional Kaizens and continuous improvement initiatives from conception to closure, with specific focus on Quality and Laboratory driven improvements.
  • Participate in Quality Management System Harmonisation activities.
  • Manage the calibration of GMP Service Providers in QC Laboratory
  • Responsible for completion of Data integrity admin checks 
  • Represent Quality in support of Deviations, Change Controls, CAPAs, etc., including active participation in investigations and problem resolution.
  • Complete batch record review and perform API Product Release.
  • Prepare, review data & reports including quarterly and annual product quality review reports. 
  • Participate in the Internal Auditing program. 
  • Participate in the Supplier Management program.
  • Lead method development and validation initiatives.
  • Edit, review and approve GMP documents.
  • Ensure that EHS roles and responsibilities are complied with as per the requirements of the site Safety Statement.
  • Perform other related duties as assigned from time to time based on company needs.

 

Required Skills & Background

 

Applicants must have the following:

  • Bachelor’s Degree in Science or related pharmaceutical discipline
  • Minimum of 3 years’ experience working in a cGMP role in a pharmaceutical environment.
  • Desirable evidence of Continuous Professional Development.
  • Understanding of EU GMP Complexity.
  • Good organizational skills and attention to detail.
  • Requires good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.
  • Ability to prioritize, manage multiple tasks, and meet deadlines

 

Training: Full training on all the responsibilities of this role will be provided.

 

Successful applicants can expect to join an enthusiastic, energetic and hard working team.

Guerbet is an equal opportunities employer and welcomes applications from all sections of the community.