Quality Control Analyst - Packaging and Containers

Description

Job Summary: Professional responsible for performing product, material, and raw material analyses in a quality control laboratory, ensuring regulatory compliance. Key Highlights: 1. Laboratory analysis experience and equipment handling. 2. CAPA management, change controls, and out-of-specification results. 3. Procedure development and updating, and participation in audits. **The Position** --------------- Perform product, material, and raw material analysis activities in accordance with the quality control department’s schedule and applicable good practices regulations and procedures. **Responsibilities** ------------------------------ * Perform laboratory analyses, sampling, and documentation review per the work plan and current procedures. * Implement and validate analytical methods, and conduct monitoring related to validation processes. * Ensure compliance with good practice standards (laboratory, manufacturing, and documentation), health, safety, hygiene, and applicable regulations. * Identify and report deviations, incidents, or discrepancies in processes or equipment per established procedures. * Manage and follow up on corrective and preventive actions (CAPAs), change controls, and out-of-specification/trending results. * Develop and update procedures (SOPs/WIs) and risk analyses (FMEA/AMEF). * Participate in internal and external audits. * Comply with 5S standards for order and efficiency, and optimize resource utilization. * Complete required training and support onboarding and training of new hires. * Monitor performance indicators (lead time, performance) and participate in alignment meetings (Tier). **Requirements** **:** -------------------- **Mandatory** --------------- * Professionals holding a bachelor’s degree and valid professional license in chemical-biological fields, such as Pharmaceutical Chemist-Biologist (QFB), Industrial Pharmaceutical Chemist (QFI), Parasitological Bacteriologist Chemist (QBP), Pharmaceutical Engineering (IF), Biology, or related disciplines. * Minimum two years’ experience in a quality control laboratory as a laboratory analyst, including hands-on equipment and lab material handling. * Knowledge of ALCOA principles. * Advanced level of English proficiency. **Desirable** * Knowledge of sampling, including ANSI sampling tables, and physicochemical analysis. * Knowledge of SAP.