Validation Analyst

Description

Job Summary: Work on technical analysis, operation, calibration, and qualification of laboratory equipment and utility systems, promoting innovative and safe solutions. Key Highlights: 1. Leader in sterile drug compounding 2. Specialized team dedicated to improving access to medications 3. Focus on regulatory rigor and excellence **About the Company** We are Pharmédice, a leader in sterile drug compounding. Founded in Minas Gerais, Pharmédice Manipulações Especializadas redefines excellence in sterile drug compounding for human health. Pharmédice not only meets the industry’s highest compounding standards but elevates them to a new level. We combine regulatory rigor, intelligent use of data, and unparalleled expertise to deliver sterile medications rapidly and with quality. Our team comprises pharmacists specialized in various fields, technicians, specialists, engineers, analysts, supervisors, IT professionals, commercial staff, logistics personnel, and procurement specialists—all united by the same purpose: ensuring market access to hard-to-obtain medications. **So, if you believe you are an exceptional professional ready to make a difference in our national structuring and growth, join us!** **Mission:** Perform technical analysis, operation, calibration, and qualification of laboratory equipment and utility systems; promote innovative and safe solutions aligned with sectoral regulatory agency requirements. **Education:** Bachelor’s degree completed in Chemical Engineering, Mechanical Engineering, Mechatronics Engineering, Electrical Engineering, or Pharmacy. **Skills:** * Affinity with Technology * Communication * Organization * Proactivity * Teamwork * Willingness to Learn **Responsibilities:** * Develop protocols and certification reports for laboratory equipment (Biological Safety Cabinets, Autoclaves, Laminar Flow Hoods, Ovens, Freezers, etc.), utility systems (HVAC and WFI), and instrument calibration, aligning with Good Manufacturing Practices and regulatory standards; * Oversee external suppliers during periodic qualification, calibration, installation, commissioning, and start-up of critical equipment and systems; * Manage certification schedules with the PCM Analyst in the CMMS software; * Conduct risk analysis and action plans for non-conformities and deviations occurring in the department; * Support internal and external audits conducted by regulatory agencies; * Interface with Quality Assurance and Quality Control, Production, Procurement, and other departments to ensure compliance of actions. **Requirements:** * Knowledge of Good Manufacturing Practices and pharmaceutical regulations; * Experience in equipment and system certification within the pharmaceutical industry; * Knowledge of Clean Utilities (HVAC, PW, and WFI). **Benefits** * Meal Allowance: BRL 23.00/day * Transportation Allowance / Fuel Assistance * UsiSaúde Health Plan (no monthly fee, only co-payment) * Dental Plan (optional) * SESC Agreement * Araújo Agreement * Working Hours: 8:00 AM to 5:48 PM, Monday to Friday Work Model: On-site / CLT Compensation: BRL 6,400.00 per month Work Location: On-site