States considered: ciudad de méxicorole descriptionthe affiliate qo coordinator is located within mexico zoetis country office for specific markets responsibilities relating to oversight of product quality activities and associate gmp/ gdp activities.in addition, he/ she will carry out all supporting activities required to meet legally defined requirements of the licencing bodies.
he/ she is responsible for the quality management system (qms), ensuring its use and its ongoing suitability for the business and gmsthe affiliate qo coordinator is also responsible for developing and maintaining the site quality manual in veeva vault, site quality system policies, procedures and quality records to comply with local qms requirement and harmonized with the global qms.the affiliate qo coordinator will oversee quality matters and provide expert advice and direction to the business and the country leadership team.
this function supplements any local or statutory quality activities or requirements.the holder of this role is part of the regulatory and quality leadership team, helping to manage the business area's functioning, developing the strategic focus for the team and generate new ideas to move the business forward, improve efficacy and maintain legal compliance.main responsibilitiesquality assurancequality system implementation & management oversightbe the affiliate qo for mexico, camcar and colombia; the nominated contact person located in mexico, for any quality related issues as required by zoetis gmsmonitor, review the performance of the qms with scl qo.
act to assure its maintenance, continued suitability and implement any improvements neededensure colleagues are appropriately trained on all necessaryroutine in country quality activities and deviation managementinvestigation and resolution of product quality and compliance related issuestemperature excursion escalationstop distribution, recallschange managementcontractor quality oversight (where managed by zoetis mexico, camcar and colombia markets)monitor and communicate local moh requirementsensuring audit readiness and hosting gqca auditors on country zoetis affiliates audits.development and maintenance of consistent quality cultureperform qm setup and approval for sap item master setup using mdg toolperform qa releases of zoetis products to the market, using sap and corresponding systems in mexico and colombia.ensure all sap actions are planned, monitored and executed for the business.attend quality meetings for critical product quality issues, representing the businessesprepare required documentation for product quality complaints that require quality/ market actionlead the zoetis action to address product quality or compliance issues identified when the product is distributed in the market.audit suppliers to assure continued fitness for provision of goods and services to zoetis.compliancemaintain high standards of business conduct and compliance, adhering particularly to pharmacovigilance policy, global vet policy, zoetis quality standards and the qms, zoetis values, travel & expenses policy and local codes of practicerelationshipsaccountable for establishing appropriate professional partnerships, agreements and communication processes with in-market teams especially, supply chain and logistics, regulatory, scl qo, commercial service to ensure continuously improving quality performance service levels and objectives are achieved in alignment with approved budgets.works closely with the team of scl qo in the latin americandrives agreed implementation of changes that enhance performance, productivity and cost.qualifications (training, education & prior experience)education:bachelor's degree in a life science, pharmaceutical science, veterinary, chemistry, biology or equivalentit literate.
able to use standard business software, communication tools and quality management systemsexperience:proven quality management experience (5+ years) in animal health/human health pharmaceutical environmentmust be proficient in the knowledge of current good distribution practices (gdp), iso quality requirements, who and applicable regional pharmaceutical legislation and regulationsexperience of the workings and practises of industry bodies e.g., sader, cofepirs, ica, etc.problem solving in a volatile environmentworking knowledge of pharmaceutical product transportation channels and lspsdemonstrated ability to operate successfully in a matrix organizationskills:analytically minded with strong attention to detail and problem-solving skillsexceptional communication skills; written and verbalexceptional relationship management, interpersonal skills and influencing abilitieseffective time management, prioritisation, and organisational abilitiesworks effectively to deadlines and under time pressuresmulti-tasking skills, ability to meet multiple and overlapping deadlinesstrong business and financial acumen with a keen commercial mind.other commentariesenglish level: bilingual efficiency (spanish and english) as a minimumpreferred place of residence: ciudad de méxicofull time