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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

 

Change Controller

OUR NEED:

 

Our site Change Controller is a key member within our Quality Systems realm. Responsible for compiling technical documentation, assess compliance and verify that control has been maintained through the organization. Maintain a relationship with our regulatory partners, domestic and internationally ensuring support and alignment with product filing.

 

YOUR DUTIES:

 

  1. Administration of Change Controls and APQRs
  2. Sustain efficient and effective change control process to maintain required product compliance.
  3. Review and sign off change control documentation. Assess changes and their impact to the current filings based on an understanding of regulatory guidelines and company policies
  4. Support Chemistry, Manufacturing, and Controls (CMC) changes made to maintain the lifecycle of the approved drugs.
  5. Participate in regulatory actions such as field alerts or product recalls, including mock recalls.
  6. Maintain awareness of MHRA/HPRA/EMA/FDA, etc. regulatory actions that may affect company products.
  7. Interact with the company's various departments to obtain documentation required for the APQRs.
  8. Support regulatory assessments, reporting and submissions to Change Controls and APQRs.
  9. Assist in regulatory inspections and post marketing product surveillance activities.
  10. When appropriate, assist in regulatory notification or market correction activities
  11. Initiate, author, revise or assist in the review of SOPs, and other cGMP documentation including but not limited to CAPAs and Deviations
  12. Provide metrics regarding key performance indicators
  13. Assist as needed in the preparation of data for internal audits and external audits/ inspections
  14. Review technical documents for accuracy and acceptability for use in a new ANDA, NDAs, Amendments, Supplements Annual Reports and other required FDA
  15. Quality*Stream System Administrator at the site.

 

 

YOUR BACKGROUND:

 

Education required/ preferred:

BS degree in Science Field

Experience:

Minimum 6 years’ experience in a pharmaceutical setting preferred;

3-5 years of pharmaceutical industry and regulatory compliance audit experience;

strong computer skills – specifically with Microsoft Office software package;  working knowledge of cGMPs

Preferred Skills/Qualifications:

Regulatory Affairs Certification; ASQ Certified Auditor; problem solving, decision making and supervisory skills

Skills/Competencies:

Statistical analysis skills: strong communication skills and attention to detail; ability to plan, schedule and arrange work activities as appropriate