Validation and Qualification Analyst

Description

Position Summary: We are seeking a professional with QA/QC or Engineering background in the pharmaceutical industry, focused on drafting and executing qualification and validation protocols, ensuring GMP compliance. Key Highlights: 1. Experience in QA/QC or Engineering in the pharmaceutical industry. 2. Participation in qualification and validation of equipment, utilities, and processes. 3. Development of technical protocols and reports ensuring regulatory compliance. **Requirements** * Chemical technicians, students, or graduates in Pharmacy, Chemistry, Biochemistry, Engineering, or related fields. * Minimum 2 years of experience in **Quality Assurance, Quality Control, or Engineering** within the pharmaceutical industry. * Strong motivation and enthusiasm to train in one of the most comprehensive and challenging activities in the industry. * Knowledge of GMP regulations and international guidelines will be valued. * Teamwork skills, proactivity, and good organizational abilities. **Job Responsibilities** * Draft, review, and execute qualification protocols (IQ/OQ/PQ) for equipment, HVAC systems, critical utilities, and cleanrooms at client facilities. * Draft and review procedures, risk assessments, user requirements specifications, validation plans, and all related documentation. * Participate in equipment, utility, and area qualifications, as well as process validation, cleaning validation, and analytical method validation strategies. * Prepare technical reports ensuring traceability and regulatory compliance. * Ensure all activities comply with applicable GMP guidelines and international regulations (ANMAT, FDA, EMA).