Loading...
Share this Job

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

 

Quality Assurance Analyst

Description

    The Quality Assurance Analyst will be responsible for providing support on the following activities and initiatives for Guerbet México:

•    Assist to establish, implement, develop and maintain the Quality Management System to ensure compliance to cGMP/cGDP, company policies and procedures and assist to maintain the company in totally complaint with the legislation.
•    Approve or reject products that are not suitable for sale and establish a system to quarantine and reject or release products that may have been the subject of a quality investigation or deviation.
•    Assist the sanitary responsible during on-site audits by clients, as well as carry out external audits when required.
•    Liaise with the Logistics function and oversee all cGMP / GDP aspects of the contract warehouse and the importation and distribution of finished products.
•    Ensure the efficient generation and translation of certificates of analysis for all products supplied.
•    Assist to develop the plan for quality by providing guidance in the expectations of pharmaceutical and medical devices customers, and assurance that the extent to which GMP/GDP, agency guidelines, and internal policies should be applied to the processes and products of the site to meet customer expectation and corporate requirements.
•    Develop and maintain the investigation and processes to comply with corporate guidelines coordinate the reporting, investigation, analysis, and resolution of all deviations and other non-conformance incidences.
•    Maintain deviation and other non-conformance incidence investigation records.
•    Provide support in the complaint process and ensure that responses are provided to customers.
•    Provide quality assurance appraisal and approval or disapproval of suppliers, as applicable.
•    Conduct internal and external quality audits and determine adequacy of subsequent preventive actions.
•    Review procedures that impact on the quality of the products to ensure compliance with cGMP and company policy and to meet customer needs.
•    Maintain information in various QA databases and produce reports as needed.
•    Develop and conduct training programs regarding company quality systems.
•    Liaise with manufacturing site personnel regarding quality aspects for the products supplied (Certificate of analysis).
•    Provide technical support and advice to our internal sales team, customer service and logistics personnel, customers, sales agents and distributors as required.
•    Assist in the Technovigilance / Pharmacovigilance processes according to local legislation and corporate policies.
•    Comply with ComplianceWire's good practice guidelines as a Key User, which include: 
•    Support the end users of the platform.
•    Create and update training programs working with Subject Matter Experts (Quality, EHS, Production, etc.) and the Administrator.
•    Resolve or report incidents to the Administrator.
 

Required Skills & Background

Education:
Bachelor's degree or equivalent in health sciences, chemical pharmaceutical discipline, or related (Essential).


Experience:
2 years pharmaceutical and/or related medical devices experience
Experience in a GMP/GDP environment 
Quality management systems / auditing


Skills/Competencies: 
•    Adaptable and flexible to accommodate the wide variety of job requirements
•    Ability to change direction and priorities quickly if needed creative problem solving
•    Ability to analyse data, and be well versed in investigation techniques to determine root causes of OOS results and exceptions 
•    Cross cultural respect
•    Demonstrates an open-minded approach to all individuals, without prejudice customer focus
•    Professional, credible individual with ability to influence others and ably represent the company
•    Tactful and diplomatic, especially when dealing with external auditors and customers drive for results
•    Consistently meet deadlines and respond to requests in a timely manner
•    Ensure company compliance with all QA corporate requirements
•    Maintain continual improvement in QA management systems interpersonal Relationships