* Provide technical guidance and expertise to laboratory staff on analytical methods, instrumentation, and data interpretation. * Develop, implement, and maintain Standard Operating Procedures (SOPs) and work instructions for all testing activities. * Oversee the validation and verification of analytical methods, ensuring their suitability for intended use. * Manage the maintenance, calibration, and qualification of laboratory equipment and instruments. * Troubleshoot technical issues and implement corrective and preventive actions (CAPA). * Stay abreast of the latest advancements in analytical techniques and regulatory requirements. * Quality Assurance and Compliance: * Ensure the laboratory operates in compliance with relevant regulatory guidelines (e.g., GMP, GLP, ISO 17025) and company quality standards. * Participate in internal and external audits and implement necessary corrective actions. * Manage the laboratorys quality control program, including the monitoring of critical quality parameters. * Maintain accurate and complete laboratory records and documentation. * Contribute to the development and implementation of the laboratorys quality management system. * Team Management and Development: * Supervise, mentor, and evaluate the performance of laboratory analysts, technicians, and other technical staff. * Assign tasks, set priorities, and ensure efficient workflow within the laboratory. * Identify training needs and facilitate the professional development of team members. * Foster a positive and collaborative work environment. * Conduct regular team meetings and communicate effectively with staff. * Operational Efficiency and Improvement: * Monitor laboratory performance metrics and identify areas for improvement in efficiency and turnaround time. * Implement lean laboratory principles and process optimization initiatives. * Manage laboratory resources effectively, including consumables, reagents, and equipment. * Contribute to the budgeting process and ensure cost-effective operations. * Reporting and Communication: * Prepare and present technical reports, summaries, and data analysis to management. * Communicate effectively with internal stakeholders (e.g., Quality Assurance, Production, Regulatory Affairs) and external clients. * Participate in project meetings and provide technical input. Standard operating procedures,quality assurance,internal audit,auditing,internal control,internal control review,enterprise risk management,sox compliance,business process review,risk management,risk assessment,gmp,software testing,sop,production