Validation Technician

Description

Job Summary: We are seeking a Validation Technician to ensure compliance with GMP regulations and regulatory requirements in a pharmaceutical environment. Key Highlights: 1. Manage and coordinate validation projects as the technical reference. 2. Ensure compliance with GMP, FDA regulations, and corporate procedures. 3. Identify issues and propose solutions for continuous improvement. **Job Description** ------------------- **Validation Technician\-MUNRO\- L aV 8 a 17 hs** We are seeking a **Validation Technician** to join a highly regulated pharmaceutical environment, focused on process, cleaning, and transportation validation, ensuring compliance with GMP regulations and regulatory requirements. **Key Responsibilities:** * Manage and coordinate validation projects, acting as the technical reference for internal and external customers. * Review and approve documentation associated with the lifecycle of manufacturing, packaging, cleaning, and transportation process validation. * Ensure compliance with GMP, FDA regulations, and corporate procedures through review and updating of quality documentation. * Prepare periodic product reports (PQR/APR) and GMP documentation related to qualifications and validations. * Manage change controls, CAPAs, and associated investigations. * Identify issues and propose solutions oriented toward continuous improvement. **Requirements:** University degree in Chemical Engineering, Pharmacy, Biology, or related fields. Minimum 3 years of experience in validations and qualifications within the pharmaceutical industry. Solid knowledge of process validation in GxP environments and good documentation practices. Advanced English **We Especially Value:** * Experience in regulatory audits (FDA, AEMPS, among others). * Knowledge of cleaning validation. * Experience in sterile areas. * Master’s degree in Pharmaceutical Industry. * Advanced proficiency in Microsoft Excel and PowerPoint. If you are interested in joining a high-impact quality and validation team in the pharmaceutical industry, we want to meet you! \#LI\-LM10