QUALITY ASSURANCE ANALYST

Description

**Mission** Ensure that all stages of production processes comply with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP), guaranteeing product quality, safety, and integrity. Structurally conduct investigations of deviations, non-conformities, and complaints, identifying root causes, performing technical analyses, and proposing corrective and preventive actions to prevent recurrence. **Professional Responsibilities:** Ensure compliance with established standards and procedures to guarantee product quality; Ensure dissemination and updating of the Quality Manual; Perform qualification of suppliers of raw materials, packaging materials, distributors, and other partners affecting product quality; Draft, distribute, and archive quality-related documents, ensuring they are reviewed, updated, and available in respective departments; Evaluate non-conformities, conduct investigations, and propose corrective and preventive actions; Investigate customer complaints, perform technical analysis, and maintain formal records; Review Manufacturing Orders (templates, analysis, approval, distribution, and management); Verify complete batch dossiers, decide on release or rejection, and assign commercialization status; Review and monitor the Master Validation Plan, establish protocols, and track implementation; Define and monitor calibration, preventive maintenance, and qualification schedules for equipment and facilities; Develop and execute qualification protocols for equipment and validation protocols for processes, cleaning, water systems, and facilities; Manage the Quality Training Program, including development/update of internal training materials, delivery of training sessions, attendance registration, evidence collection, refresher training, and updating the training matrix in partnership with the Human Resources Department (DHO); Control mandatory training to ensure compliance with GMP, GDP, internal procedures, and regulatory requirements; Manage the Change Control process, assessing impacts, logging requests, conducting risk analyses, coordinating approvals, ensuring proper implementation, and maintaining complete documentation; Contribute to maintaining certifications and the Quality Management System, ensuring guideline updates and participation in internal and external audits; Handle support tickets via Zendesk system, including opening Non-Conformance Reports (NCRs), tracking corrective actions, and formally communicating responses to customers. **Requirements:** Bachelor's degree in Pharmacy, Quality, Chemistry, Biology, or related fields; or currently enrolled; Minimum 1 year of experience in Quality; Quality Management Systems; Quality tools (Investigation, Risk Analysis); Good Manufacturing Practices. Minimum Education Level: Bachelor's Degree