Position Summary: Perform product, material, and raw material analyses according to the Quality Control schedule and applicable GxP regulations, ensuring compliance and continuous improvement. Key Highlights: 1. Execution of analyses, sampling, and documentation review. 2. Implementation of analytical methods and validations. 3. Knowledge of GLP, GMP, and pharmaceutical regulations (FDA, USP). **The Position** --------------- Carry out product, material, and raw material analysis activities in accordance with the Quality Control department’s scheduled plan and in full compliance with applicable GxP regulations and procedures. **Responsibilities and Duties** ------------------------------ * Perform all analytical activities, sampling, documentation review, and laboratory logbook entries in accordance with the established work plan and applicable procedures. * Carry out method implementation, analytical validation, and monitoring activities arising from critical system validations and manufacturing process validations. * Ensure adherence to 5S principles and appropriately utilize and optimize company resources. * Perform all activities in strict compliance with GLP, GMP, GDP, Health, Safety and Hygiene requirements, PT/PNO procedures, internal regulations, and current regulatory requirements. * Report any discrepancies in processes or activities, as well as laboratory equipment-related incidents, per established procedures. * Execute and follow up on corrective and/or preventive actions arising from deviations, out-of-specification (OOS) and/or out-of-trend (OOT) results, laboratory events, audit observations, and change control activities. * Draft and/or update procedures (PNO/PT) related to assigned activities. * Actively participate in audit responses. * Conduct Risk Analysis (FMEA/AMEF), evaluating applicability based on area expertise. * Timely fulfill required training and qualification activities necessary for proper performance of duties and maintenance of qualification status. * Participate in on-the-job training (OJT) for newly hired personnel. * Meet established lead time and performance indicators for the department. * Actively participate in status alignment meetings (Tier meetings). **Requirements** **:** -------------------- **Mandatory** --------------- * General knowledge and skills regarding laboratory analytical processes and associated equipment. * Basic knowledge of statistical and administrative quality control tools. * Proficiency in Good Laboratory Practices (GLP) and documentation practices; familiarity with Good Manufacturing Practices (GMP). * Knowledge and application of national and international pharmaceutical regulations, standards, and guidelines (FDA, USP, EMA, ICH, HPB, SSA FEUM, SAGARPA). * Familiarity with official compendia such as FEUM, USP, EP, JP, etc. * Proficiency in Empower, TrackWise, and SAP systems. * Bachelor’s degree in Chemical-Biological disciplines (e.g., QFB, QFI, QBP, IF, B, etc.) or closely related field. * Valid professional license (cédula profesional). * English language proficiency at 70% (100% reading and comprehension of technical English). **Desirable** * Experience in Gas Chromatography (GC). * Experience in raw material analysis.