Senior Quality Analyst - (29768)

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

WHAT WE'RE LOOKING FOR

We are seeking a dedicated and experienced Senior Quality Analyst to join our team. This role is crucial in ensuring the highest standards of quality and compliance within our organization. You will be responsible for maintaining and enhancing our Quality Management System, overseeing product quality, and supporting various quality assurance activities. This position is located in CDMX.

YOUR ROLE

Establish, implement, develop, and maintain the Quality Management System to ensure compliance with cGMP/cGDP, company policies, and procedures.
Approve or reject products that do not meet quality standards and manage the quarantine and release of such products.
Oversee all cGMP/GDP aspects of the contract warehouse and the importation and distribution of finished products.
Generate and translate certificates of analysis for all supplied products.
Develop quality plans and ensure compliance with GMP/GDP, agency guidelines, and internal policies.
Coordinate the reporting, investigation, analysis, and resolution of all deviations and non-conformance incidents.
Maintain records of deviations and non-conformance incidents.
Support the complaint process and ensure timely responses to customers.
Conduct internal and external quality audits and ensure adequate preventive actions.
Review procedures impacting product quality to ensure compliance with cGMP and company policies.
Develop and conduct training programs on company quality systems.

YOUR BACKGROUND

Education:

Bachelor’s degree or equivalent in health sciences, chemical pharmaceutical discipline, or related field (Essential).

Experience:

3-4 years of experience in the pharmaceutical and/or medical devices industry.
Experience in a GMP/GDP environment and Quality Management Systems/auditing.

Skills/Competencies:

Adaptability: Flexible to accommodate a wide variety of job requirements and able to change direction and priorities quickly.
Creative Problem Solving: Ability to analyze data and use investigation techniques to determine root causes of issues.
Cross-Cultural Respect: Open-minded approach to all individuals, without prejudice.
Customer Focus: Professional and credible, able to influence others and represent the company effectively.
Drive for Results: Consistently meet deadlines and ensure company compliance with QA corporate requirements.
Interpersonal Relationships: Ability to maintain continual improvement in QA management systems and work effectively with others.

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