Quality System Coordinator
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TASKS AND RESPONSABILITIES 

• Manage the review, validity and obsolescence of the documentation system as well as technical and quality specifications. As well as ensuring Data Integrity (DI) in the different quality systems on site. Manage the Quality System: Quality System Review (QMR), Internal Audits, Deviations, Local and External Change Control (SYNAP – CH and BASIC – PH), Out of Specification Result (IRFES / OOS), Customer Complaints (PH, CH, Medical Devices) and Supplier (Maquilas and other Bayer sites), Training (Lerma inuating to CEDIS), Annual Product Review (product manufactured in Plant and by Maquiladoras), Risk Analysis and Transfer of Regulations (CMS) that apply on the Lerma site.
• Prepare reports on complaints received as well as trends in deviations, IRFES, internal audits and risk analysis as well as follow up on the actions generated.
• Participate in the preparation of protocols and reports for the validation of processes, as well as criticalsystems: environmental monitoring (viable and non-viable particles), trends in Purified Water, Compressed Air, and follow-up on the actions generated.
• Develop the b-lactam monitoring protocols and reconditioning protocol for the Distribution Center and keep records of the results obtained, as well as the corresponding report.
• Manage and perform the recall drill as well as the Market Product Recovery.
• Prepare the shipment of special handling products (Cold Chain), shipments of products to countries that require temperature monitoring and verification of transportation conditions during shipment from the maquiladora until the receipt of products.
• Perform the verification of the physical product against the records in the SAP system (N8P).
• Perform internal audits and coordinate and maintain the system. Perform supplier audits (when applicable) and execute the supplier qualification process.
• Prepare the technical documentation for the presentation of files to the health authorities and review of the dossier, as well as be responsible for and provide support for analytical validation-transfer issues. Manage and follow up on the implementation of the regulations that apply to the site in accordance with the Mexican authorities COFEPRIS and regulations of countries to which we market products (ICH, FDA, INVIMA, ANVISA, TGA, etc.).
• Prepare the technical documentation of technical dossiers for presentation with the regulatory affairs departments, LATAM and USA. And ensure that the dossiers (medicines, medical devices, hormonal products, biotechnology, cosmetics and food supplements) comply with the requirements of COFEPRIS.

WHO YOU ARE

• Pharmaceutical Chemist Biologist or areas to end.
• Minimum 2 years of experience in the management of quality systems. Level.
  Intermediate English
• Pharmaceutical Chemist Biologist or related areas.
• Minimum 2 years of experience in the management of quality systems.
• Competencies: -Customer orientation -Push to get results -Complexity management -Handling ambiguity -Courage.

WHAT WE OFFER YOU

• Full time employment contract.
• Wide range of development opportunities.
• Competitive salary.
• Attractive benefits package.
• Good working conditions and comfortable working environment.

At Bayer we believe in diversity, equity and inclusion. We aim to create an environment in which everybody can feel authentic, respected and equally valued. Every day we strive to reflect our values through our people unique capabilities, self-experiences, and aspirations. We, intentionally seek diversity, to enable our people bring their fullest potential out and encourage others to likewise do so. Our company wins, when we leverage our capabilities to lead the cultural transformation in our business, positively impacting the society.

Candidates who meet the requirements based on the job profile will be considered for employment regardless of physical disability, race, color, religion, sex, age, sexual orientation, gender identity and will not be at a disadvantage if unemployed.