Oversee all analytical testing activities to ensure compliance with cGMP, GLP, ANVISA RDC,and other applicable regulatory requirements, ensuring data integrity, accuracy, and traceabilitythroughout all operations, maintaining the laboratory in a state of inspection readiness.- Ensure robust method transfer processes are in place and executed effectively, collaboratingclosely with R&D, manufacturing, and third-party contractors.- Drive the timely release of analytical results within schedules while maintaining stringentquality standards.- Manage the acquisition, qualification, calibration, and maintenance of all QC laboratoryequipment and instrumentation.- Oversee the entire process for chemicals, reagents, and reference standards management, fromprocurement to disposal, ensuring supply chain integrity and compliance.- Establish and maintain robust quality systems within QC, including OOS/Deviationmanagement, CAPA effectiveness, change control, and risk management. Provide strategicdirection for complex method troubleshooting, OOS investigations and other quality relatedprocess.- Forecast and manage the departmental budget, including staffing, equipment, consumables, andexternal services.- Develop and implement the strategic vision and operational plans for the QC department,aligning with the company's overall business objectives and quality goals.- Actively participate in internal and external regulatory audits (e.G., ANVISA, client audits),providing expert responses and presenting laboratory data and processes.- Act as a primary point of contact and subject matter expert for all QC-related discussions duringinternal and external audits. Lead the preparation and response to audit findings, ensuringtimely and effective CAPA implementation and closure.- Stay abreast of new and evolving pharmaceutical regulations and industry best practices,ensuring the QC department remains fully compliant.- Establish and monitor departmental Key Performance Indicators (KPIs) to drive efficiency,compliance, and quality improvements.- Oversee recruitment, training, performance management, and career development for all QCpersonnel. Ensure adequate staffing levels and competencies to meet operational demands andfuture growth.- Conduct performance reviews, provide constructive feedback, identify training needs, andsupport the professional development of team members.- Promote a strong safety, continuous improvement and proactive problem-solving culture withinthe laboratory, ensuring all team members adhere to EHS policies and procedures.- Collaborate effectively with other departments such as Manufacturing, Quality Assurance,Regulatory Affairs, R&D, Supply Chain, and Project Management to ensure seamlessoperations and achieve company goals.- Participate in management review meetings, product development teams, and other cross-functional committees as required.Experience- 5 to 15 Years