SENIOR EQUIPMENT VALIDATION ANALYST - ADMINISTRATIVE SHIFT - ANÁPOLIS

Description

Job Summary: We are seeking talented individuals to transform possibilities into reality, contributing to the best and most comprehensive Brazilian pharmaceutical company, with a focus on equipment qualification. Key Highlights: 1. Working for the best and most comprehensive Brazilian pharmaceutical company 2. Management of qualifications and regulatory compliance 3. Technical interface with engineering, production, and quality assurance We seek talents who can transform possibilities into reality and contribute to maintaining our position as the best and most comprehensive Brazilian pharmaceutical company, participating in people's lives so they can live longer and better. This opportunity is open to all candidates, regardless of sexual orientation, social accessibility, or any other factor. All our positions are open to Persons with Disabilities (PwD). Don’t see yourself reflected in this role? Don’t worry! You can still join our team! Register in our talent pool — as soon as an opportunity better aligned with your profile arises, we’ll contact you! **Responsibilities and Duties** * Drafting/Reviewing qualification-related documents (QP/QI/QO/QD), ensuring compliance with RDC 658/22, PIC/S Annex 15, FDA 21 CFR, WHO TRS; * Defining qualification strategies through risk analysis (FMEA), establishing technical and regulatory criteria; * Monitoring internal qualification activities and those conducted by service providers. * Preparing technical qualification reports (QP/QI/QO/QD), including critical evaluation of results, deviation handling, and technically substantiated conclusions; * Participating in FAT/SAT, verifying documentary compliance with suppliers; * Managing deviations and CAPAs related to qualification activities; * Managing change control with regulatory impact assessment related to qualification; * Technical interface with engineering, production, and quality assurance to ensure adherence to GMPs. Participation in self-inspections and regulatory inspections (ANVISA and other regulatory authorities); * Managing the qualification plan; participating in annual and monthly activity planning, providing technical support for planning and distribution of tasks. **Requirements and Qualifications** * Bachelor’s degree completed in Engineering, Chemistry, Pharmacy, or related fields. * Advanced English proficiency (writing, reading, and speaking) — preferred; * Proficiency in Microsoft Office 365 * Project management skills and ability to lead multidisciplinary activities * Experience in Equipment and Utility Systems Qualification (HVAC, Purified Water System - PW, Compressed Air, Nitrogen); * Experience in drafting, reviewing, and executing equipment and utility systems qualification protocols; * Knowledge of Good Manufacturing Practices (GMP) per RDC 658/22 * Familiarity with applicable standards and regulations governing equipment and utility systems qualification (RDC 658/22, IN 138/22, ABNT 16328, ABNT 17665, ISO 14644, ISO 8573, PIC/S Annex 15). **Additional Information** **Main Benefits:** -------------------------- * Medical assistance; * Dental assistance; * Life insurance; * Meal allowance or on-site cafeteria **(depending on the unit)**; * Food allowance; * Transportation allowance, shuttle service, or parking **(depending on the unit)**; * Wellhub; * Internal pharmacy — company medications at no cost, extended to spouse and children **(depending on the unit)**; * Nova Vida Tem Valor Program (telemedicine, maternity kit, courses, co-payment exemption during pregnancy and postpartum, among others); * Health Space — medical assistance services **(depending on the unit)**; * PPR / Bonus **(depending on the unit)**; * **Tem Valor Benefits Club:** E-commerce platform featuring numerous partner companies offering products and services with exclusive, differentiated discounts; * **Tem Valor Mini-Store** (e-commerce with up to 40% discount on our dermocosmetic and vitamin products); * **Online Psychotherapy** — free and confidential; * **Childcare Assistance** **(subject to unit and internal policy)**; **Note: Internal applications are accepted for this opportunity.** **Published on:** 11/05/2026 **Internal Application Period:** until 17/05/2026 **Responsible Analyst:** XXXXX