Quality Assurance

Description

Job Summary: We are seeking a Quality Assurance Chemist with experience in pharmaceutical quality management systems to design, implement, and improve the client's quality system. Key Highlights: 1. Integration into a specialized project in the pharmaceutical sector 2. Opportunity for professional development in high-level quality management systems 3. Participation in the implementation and improvement of critical processes **Position: Quality Assurance Chemist** We are looking for a professional with solid technical training and experience in Quality Management Systems within the pharmaceutical sector, who will contribute to the design, implementation, and continuous improvement of the quality system at a client company. **Requirements:** * Bachelor’s degree in Pharmaceutical and Biological Chemistry (QFB) or Industrial Pharmaceutical Chemistry. * Experience in Quality Management Systems in the pharmaceutical industry. * Solid knowledge of applicable national and international regulations. **Technical Knowledge:** * NOM\-059, NOM\-073\. * ISO 9001:2015 and ISO/IEC 17025:2017\. * ICH and WHO guidelines. * Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). * Analytical method validation. * Statistical process control. * Team management. * Planning, execution, and reporting of audits and self-inspections. * Management of nonconformities and corrective/preventive actions (CAPA). **Responsibilities:** * Design, draft, standardize, and implement the Quality Management System. * Develop Standard Operating Procedures (SOPs), forms, and associated documentation. * Design and deliver SOP-related training. * Train and qualify personnel on established procedures. * Plan, execute, and document internal audits and self-inspections. * Manage nonconformities and track corrective and preventive actions. * Ensure regulatory compliance of the quality system. **Competencies:** * Advanced technical knowledge in pharmaceutical quality. * Analytical mindset and attention to detail. * Leadership in implementation and improvement processes. * Orientation toward continuous improvement. * Organizational and documentation skills. * Collaborative work with multidisciplinary teams. **Desirable:** * Certification in Six Sigma, 5S, or Lean Manufacturing. * Experience in implementing Quality Management Systems. * Experience in injectable drug manufacturing (highly valued). **We Offer:** * Integration into a specialized project in the pharmaceutical sector. * Opportunity for professional development in high-level quality management systems. * Participation in the implementation and improvement of critical processes. If you have solid experience in pharmaceutical quality and seek a high-impact technical challenge, this position is for you. Employment Type: Full-time Salary: $15,000\.00 \- $18,000\.00 per month Application Questions: * Do you have experience working with Quality Management Systems in the pharmaceutical industry? * Have you developed or implemented Standard Operating Procedures (SOPs)? * Which regulations have you directly applied (e.g., NOM\-059, ISO 9001, ISO 17025, ICH, or others)? * Have you participated in internal audits or self-inspections? * Have you implemented or tracked corrective and preventive actions (CAPA)? * Do you hold a bachelor’s degree in QFB or pharmaceutical chemical engineering? Work Location: On-site employment