Empleos de senior analyst en Ciudad de México

At Guerbet, we build lasting relationships so that we enable people to live better.

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, as well as digital and AI solutions for diagnostic and interventional imaging. As a pioneer in contrast products for the last 95 years, we continuously innovate.

Customer centricity, Cooperation, Audacity, Focus, and Responsibility are the values that we share and practice.

For more information on Guerbet, go to www.guerbet.com and follow Guerbet on LinkedIn, X, 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.