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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

 

Sr. QS Auditor

OUR NEED:

 

The Sr. Quality System Analyst, also referred to as the Independent Quality Auditor (lQA), is a resource for quality support and laboratory personnel. Primary responsibilities include quality over laboratory data review for QC Chemistry and Microbiology.  The IQA makes sound decisions to meet FDA, EU, MHRA and product requirements. Make judgments on observations during review. Have a good degree of initiative to resolve problems, discuss and research action to be taken before finalizing a resolution.  

 

YOUR DUTIES:

 

  • Support the Quality Assurance Group to provide effective, timely, and efficient oversight of the compliance of internal laboratories with the requirements of the US and EU standards.
  • Strong knowledge in quality, analytical chemistry, and microbiology, along with function of a quality control laboratory environment supporting a pharmaceutical TS facility.
  • Knowledge of cGMP, GLP, GXP, FDA, ICH, EU and 21 CFR 11 regulations, guidelines, body policies and procedures.
  • Must have good organizational, presentation, meeting facilitation and technical writing skills.
  • Strong knowledge and practical use of laboratory equipment; HPLC, GC, titrator, UV VIS, pipette, and  pH meters, Micro and Rodac plates, bio burden and endotoxin testing, etc.
  • Basic to intermediate proficiency in Microsoft Office and statistical programs (i.e. MiniTab, TotalChrom, Empower, LIMS).
  • Need to be familiar with a Quality Control laboratory environment, procedures, analysis and understanding of laboratory calculations, conversions and units.
  • Verify accurate transcription of raw data into reports and laboratory documents. Audit testing for compliance to all applicable S0Ps, methods and regulatory requirements.
  • Auditing background, and ability to work/contribute in a team-based environment as a lead and a participant, exceptional interpersonal skills, and adept problem-solving skills.

 

 

YOUR BACKGROUND:

 

BS/BA degree in Chemistry, Biology, or Life Sciences

Minimum of 6 years' experience in a pharmaceutical setting preferred, a least 2 years laboratory

    • ASQ certified inspector/auditor preferred
    • Proven ability to manage multiple projects/tasks simultaneously
    • Demonstrated self-starter with capability to develop innovative solutions to challenges
    • Knowledge of cGMP, GLP, GXP, FDA, ICH, EU and 21 CFR 11 regulations, guidelines
    • Strong computer, scientific, and organizational skills
    • Experience in conducting pharmaceutical cGMP audits
    • Excellent communication (oral and written) and attention to detail
    • Ability to work independently and as part of a team, self-motivation and adaptability
    • Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records and comply with company policies