Key Responsibilities

Laboratory Operations

• Assist in managing daily Quality Control laboratory activities.
• Supervise chemical, microbiological, and physical testing of raw materials, packaging materials, in-process samples, and finished products.
• Ensure timely analysis and reporting of laboratory results.
• Coordinate laboratory workflow to meet production and release timelines.

Quality Compliance

• Ensure compliance with GMP, GLP, SOPs, and regulatory requirements.
• Support internal and external audits, including regulatory inspections.
• Monitor adherence to quality systems and laboratory best practices.
• Participate in investigations related to deviations, out-of-specification OOS, and out-of-trend OOT results.

Documentation & Reporting

• Review analytical reports, laboratory records, certificates of analysis, and test documentation.
• Ensure proper documentation, filing, and record retention in compliance with regulatory standards.
• Assist in preparing quality metrics and management reports.

Equipment & Method Management

• Oversee calibration, qualification, and maintenance of laboratory instruments and equipment.
• Support analytical method validation, verification, and transfer activities.
• Ensure availability of laboratory reagents, standards, and consumables.

Team Leadership

• Supervise and mentor QC analysts and laboratory staff.
• Assist in staff training and competency development programs.
• Promote a culture of quality, safety, and continuous improvement.

Safety & Continuous Improvement

• Ensure compliance with laboratory safety procedures and environmental standards.
• Identify process improvement opportunities within QC operations.
• Support implementation of CAPA Corrective and Preventive Actions.