Руководитель лаборатории контроля качества

Key Responsibilities

• Plan, organize, and monitor the daily operations of the Quality Control laboratory.
• Manage the analysis of raw materials, packaging materials, intermediates, finished products, and stability samples.
• Ensure that analytical results comply with GMP requirements and relevant quality standards.
• Plan laboratory staff activities, allocate responsibilities, and manage the team.
• Coordinate investigations into OOS (Out of Specification), OOT (Out of Trend), and laboratory-related deviations.
• Contribute to CAPA, change control, deviation management, and other quality-related processes.
• Monitor analytical method validation, verification, and transfer activities.
• Oversee the commissioning of laboratory equipment and monitor calibration, maintenance, and qualification activities.
• Ensure that laboratory documentation complies with GMP requirements and data integrity principles.
• Represent the Quality Control department during internal and external audits.
• Monitor laboratory performance indicators and lead continuous improvement initiatives.

Qualifications

• Bachelor’s degree in Chemistry or Chemical Engineering.
• At least 7 years of experience in Quality Control within the pharmaceutical industry, preferably including 3 years of team management experience.
• Knowledge of GMP, GLP, and relevant quality management systems.
• Hands-on experience with analytical instruments such as HPLC, GC, UV-Vis, and FTIR.
• In-depth knowledge of analytical method validation, verification, and transfer processes.
• Experience in managing OOS (Out of Specification), OOT (Out of Trend), deviation, CAPA, and change control processes.
• Proficiency in Microsoft Office applications.
• Experience with laboratory information management systems, SAP, and QMEX documentation systems is preferred.
• Good command of English.
• Strong analytical thinking, problem-solving, and decision-making skills.
• Excellent team management and communication skills.
• Strong planning and organizational abilities.