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Laboratory Analyst – Established Pharmaceuticals
3 months ago
Position Overview
This role is situated within the Established Pharmaceuticals division, where we are dedicated to expanding access to our reliable medications in rapidly developing markets. Our extensive range of high-quality branded generic medicines spans various therapeutic fields, including gastroenterology, women's health, cardiometabolic disorders, pain management, and respiratory health.
In collaboration with fellow team members, the laboratory analyst is responsible for conducting timely evaluations of manufacturing solutions and component materials to ensure compliance with established specifications. The laboratory analyst reports to the supervisor, focusing on delivering exceptional performance and continuous enhancement in quality and compliance standards.
Key Responsibilities
Quality Control Analysis:
• Conduct sampling and analysis of raw materials, in-process products, and finished goods in alignment with the quality control framework;
• Evaluate the final product, including preparation of standards for HPLC and mobile phase, while interpreting analytical results;
• Prepare various solutions for testing purposes;
• Calibrate laboratory instruments as outlined in standard operating procedures (SOPs);
• Relay pertinent information to the appropriate personnel;
• Maintain comprehensive records of all tests, procedures, and results, including stability studies, and notify the QC Supervisor or QA/QC Manager of any non-compliance findings;
• Generate labels for the release process of raw materials and finished products;
• Conduct analyses in accordance with safety protocols and good manufacturing practices (GMP);
• Ensure a clean laboratory environment and adhere to health and safety regulations;
• Contribute to the development of SOPs.
Subject Matter Expert Support:
• Revise laboratory procedures for new systems, updates, or corrective measures;
• Oversee calibration and maintenance schedules for laboratory equipment;
• Implement and assess new laboratory instruments and systems;
• Follow up on validations conducted by the QC laboratory (both production and QC validations);
• Track and analyze laboratory key performance indicators (KPIs) and trends for monitored products and systems;
• Assist in troubleshooting analytical techniques or instrument-related issues;
• Serve as backup for audit subject matter expert representation concerning laboratory activities.
Technical Advisory Support – Inter-Departmental:
• Conduct laboratory investigations for all events impacting the QC laboratory;
• Manage communication and reception of external laboratory analyses;
• Provide analytical support to S&T or BEx for various requests;
• Facilitate training on equipment, techniques, and procedures pertinent to the QC laboratory.
Commitment to Continuous Improvement and Innovation:
• Actively participate in meetings with production and QA-QC departments;
• Strive for continuous enhancement of methods, procedures, equipment, and techniques within the QC department, proposing improvements as necessary;
• Contribute to the development of innovative techniques and methods for routine, non-routine, and project-related tasks.
Additional Responsibilities:
• Engage in the implementation of lean continuous improvement tools within the QC laboratory;
• Foster a collaborative work environment that promotes team effectiveness.
Required Qualifications
• A college degree in a scientific discipline (Chemistry, Biochemistry, etc.) with a minimum of 3 years of experience in the pharmaceutical or related industry, along with a solid understanding of chemistry, particularly HPLC;
• Over 5 years of experience in a comparable role;
• Proficient in both written English and French;
• Strong computer skills, particularly with Microsoft Office Suite;
• Capability to thrive in a continuous improvement environment (LEAN principles).
