DirecciónAs a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.
Objective:
Establish, manage, and maintain a Comprehensive Quality Management System within the Elanco Santa Clara site, combining compliance with Elanco's international Quality standards with Local Regulations, in order to ensure that all production and documentary processes of the site, support the performance and quality of the products produced at the site.
Functions, Duties, Tasks:
Implement, manage and maintain the Quality Management system covering the different requirements established in the local regulation (SADER and COFEPRIS), and that of the countries where the products manufactured in Santa Clara are distributed, in addition to complying with the different Elanco´s Quality standards (QMS) in order to ensure compliance with these and ensure business continuity for the site.
Implement, manage and maintain updated the different Quality tools (Veeva, SAP, LMS etc.) established in Elanco in order to monitor and comply with the different topics (document system, release of materials and product, training, stability studies , Audits, Deviations, Claims, Compliants, Recalls, NTM, Change Controls etc.) of local Quality and guarantee compliance with Elanco´s Quality standards on site.
Manage the resources of the Quality area and timely detect areas of investment opportunity in the area in order to keep quality analytical processes updated and in compliance with local regulatory requirements and and Elanco´s Quality standards .
Implement, manage and maintain the suppliers development and control process of raw materials, packaging materials and relevant GMP services in accordance with Elanco's Quality standards in order to guarantee the functionality of these in our production processes and quality of the products manufactured on site.
Provide direct support to all regulatory processes (Audits, verification visits, authorized professionals, Sanitary responsible, etc.) established by local and global regulatory authorities in order to comply with the different regulations applicable to site.
Provide support to relevant site projects (new product development, continuous improvement, remediation, business continuity etc.) as required to ensure business continuity on site.
Provide support in the implementation processes of the different Operational Excellence tools (Dashboards, Huddles, Gembas, etc.) at the site in order to comply with Elanco's continuous improvement standards and operational excellence.
Participation in the level three Huddles (Dashboards) carried out on the site and manage the Quality incidents of the site in the different global Quality meetings in order to maintain the escalation process (communication and escalation) in compliance and seek the solution of the same in alignment with the Elanco´s Quality Standards.
Provide Quality support to the different areas of the site in order to maintain the Qualified and Validated status of the different Technical Systems, Critical and Computerized Systems and production and Quality processes of the site.
Consistently partner and communicate with Operations, HSE, Regulatory, Supply Chain, Finance, affiliates and other areas.
Serve as a conduit for Corporate and Plant communications, objectives, projects and best practices. Strive for integration of best practices and elimination of waste across the site and other networks.
Minimum Qualifications (education, experience and/or training and required certifications):
Bachelor´s degree as (master degree´s preferably) , Biological Pharmaceutical Chemist , Industrial Biological Pharmaceutical Chemist, Pharmaceutical Engineering, Chemical Engineering or related fields.
At least 5 years of Experience in the area of Quality of the pharmaceutical, cosmetic, food industry or related and extensive knowledge in Good Manufacturing Practices (GMP), Documentation (GPD) and Engineering (GIP), National Standards (SADER, COFEPRIS ) and Data Integrity guidelines.
Extensive experience (5 years) in Quality Systems Management in the Pharmaceutical/Chemical industry or related fields.
Advanced knowledge in Continuous Improvement, Lean Manufacturing and Statistical processes tools focusing in the Pharmaceutical/Chemical industry or related fields.
At least 5 years of experience in training processes and management of high-performance work teams in areas of health and the chemical/pharmaceutical industry.
5 years of experience in resource managing (Budget) of Quality.
Advanced skills in English
Competencies: Orientation to results, Prioritization skills, written and oral communication skills, critical decision making skills, interpersonal/people skills, knowledge of computer applications, problem solving skills, and mentoring/leadership skills are required
Additional Preferences:
Availability to travel.
Experience in Production, Manufacturing, Science and Technology Services or Regulatory is desirable
Knowledge about the Safety rules
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
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