Associate-quality Control

hace 1 semana

Ecatepec, México Elanco A tiempo completo

Education : EQUIVALENTEXPERIENCE

**As 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.**

**Position Objective**:
**This position is responsible for perform the analytical, documentary and inspection processes (as required) needs to guarantee that the materials (raw materials and packaging materials) used in the production processes of the site comply with the established quality requirements and that the products released for commercialization comply with the established quality specifications, in addition to supporting different administrative processes related to regulatory compliance (ex. stability programs, validation processes and audits) and special projects of the site.**:
**Functions, Duties, Tasks**:

- Manage the correct process of sampling, analysis and release of raw materials that enter the site in accordance with good manufacturing practices in order to guarantee the correct dictum of these and the quality of the products where they are used.
- Generate and maintain updated the relevant technical information (ex. SOPs, Instructions, analytical methodology) used in the analytical and documentary processes of the laboratory (physical-chemical) in order to comply with local regulatory standards and Elanco Quality standards.
- Participate and/or provide support to relevant projects (ex. new product development, continuous improvement, remediation, business continuity and tech transfer processes) of the site when required to ensure business continuity on the site.
- Provide support in the evaluation processes of Quality events (ex.OoS, OoT, Deviations y reclamaciones) related to the laboratory area (physical-chemical) as required in order to comply with local regulatory requirements and Quality standards from Elanco.
- Provide support in the different processes (ex. Training, Deviations, Change Controls, Risk Analysis, Claims and CAPA Plans) related to the Quality Management System of the site when required, so that these are performed according the established times and adherence to Elanco's Quality standards.

**Minimum Qualifications (education, experience and/or training and required certifications)**:

- Bachelor's Degree or Engineering in Biological Pharmaceutical Chemist, Industrial Pharmaceutical Chemist, Pharmaceutical Engineering, Chemical Engineering, Biotechnology Engineering or related.
- Experience of at least 1 years in the pharmaceutical, chemical, cosmetic or food industry with knowledge of Good Manufacturing Practices (GMP), Documentation (BPD), local Regulations (SADER, COFEPRIS) and International (ex. VICH, WHO) and data integrity requirements.
- Experience (at least 1 years) in the management and execution of analytical processes using HPLC techniques, GC and general methods, transfer and validation of analytical methodology and management of stability programs for veterinary products.
- Basic handling of SAP system or equivalent. (Quality Modules)
- Handling of computer packages (Windows and Microsoft Professional Office) intermediate level.
- Intermediate level English language skills.
- Skills: Competences: Orientation to results, teamwork, and promotion of continuous improvement.

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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