Analytical Validation Supervisor

Description

Job Summary: We are seeking an Analytical Validation Supervisor to lead method validation studies and support quality management in the pharmaceutical industry. Key Highlights: 1. Lead analytical validation activities in a pharmaceutical company. 2. Collaborate on quality management and GLP compliance. 3. Work with analytical methodologies and laboratory equipment. At Asertiva Consulting, we seek talent! Do you wish to take on a new challenge and work for a company committed to continued growth? This could be your opportunity! On behalf of our client—a pharmaceutical company—we are looking for an Analytical Validation Supervisor. **PROFILE** * Bachelor's degree or higher in Pharmacy, Biochemistry, or related fields. * Preferred: training or specialization in Good Laboratory Practices (GLP), ISO 17025, or method validation. * Minimum 3 years of experience in similar positions. * Experience in the human pharmaceutical industry. * Experience operating laboratory equipment: HPLC (High-Performance Liquid Chromatography). * Knowledge of analytical methodology development. * Knowledge of analytical methodology validation. * Familiarity with statistical tools related to obtaining results for each validation performance parameter. * Knowledge of pharmacopoeias: USP, BP, EP, Merck Index, AOAC, etc. * Knowledge of quality systems: ISO 9001, ISO 17025, etc. * Basic-to-intermediate Excel skills preferred. * Basic-to-intermediate English proficiency preferred. **MAIN RESPONSIBILITIES** * Conduct literature searches in scientific journals, reference books, or other sources to guide and propose validation studies. * Execute analytical method validation studies. * Prepare protocols, reports, spreadsheets for each evaluated parameter, and method validation reports. * Support review of validation documents from service providers' validation studies. * Update analytical techniques. * Maintain inventory of reference samples and samples requested and/or designated for Method Validation processes. * Coordinate and manage nationwide sample shipments, following prior coordination with the Head of Analytical Validation. * Maintain the Kardex for reference samples and samples designated for method validation. * Track corrective and preventive actions (CAPA) whenever Out-of-Specification (OOS) results or Laboratory Investigation Reports (LIR) occur. * Support preparation of quality management documents: procedures, instructions, forms, etc. * Attend to external and internal clients. * Comply with and ensure adherence to GLP (Good Laboratory Practices). **CONDITIONS** * General Labor Regime * EPS (Health Insurance) * Performance Bonus * Profit Sharing * Corporate Discounts * Training Programs * Contract renewable every 6 months * Working Hours: 7:00 a.m. to 4:45 p.m. in Ate Salary: S/.4,500.00 – S/.5,000.00 per month Work Location: On-site employment