Job Description

Lead and manage the QC operations for injectable products, ensuring that all products meet the highest industry standards for quality, safety, and regulatory compliance. Work closely with senior management to set strategic goals for quality improvement and oversee the performance of quality control teams across the organization. Key Responsibilities: Leadership & Strategy: Develop and implement the quality control strategy for injectable products, ensuring alignment with overall corporate goals and regulatory requirements. Lead and mentor the QC team, fostering a culture of excellence and continuous improvement. Collaborate with cross-functional teams, including R&D, production, regulatory affairs, and supply chain, to ensure seamless operations and product quality. Provide strategic oversight on the quality control program for injectable products from raw materials through to finished goods. Compliance & Regulatory Management: Ensure compliance with relevant regulatory bodies , industry standards , and internal policies. Oversee the preparation and submission of quality control documentation for regulatory inspections and audits. Stay current on changes in pharmaceutical regulations, guidelines, and best practices related to injectable drugs. Ensure timely resolution of any compliance issues or regulatory findings related to quality. Quality Control Operations: Oversee the management of QC laboratories and testing for injectable drug products, ensuring the effectiveness and accuracy of all quality tests. Review and approve QC specifications, protocols, and methods for injectable products. Direct stability testing programs and ensure appropriate data handling and reporting. Develop and maintain appropriate procedures and systems for tracking quality-related incidents, complaints, and corrective actions. Continuous Improvement & Risk Management: Lead the continuous improvement initiatives within QC processes to enhance efficiency, reduce defects, and improve overall product quality. Conduct root cause analysis for quality failures and implement corrective and preventive actions (CAPA) to mitigate risks. Establish and monitor key performance indicators (KPIs) for the QC department to measure effectiveness and ensure objectives are met. Collaboration & Communication: Communicate with executive leadership to report on quality control performance and initiatives, providing insights for decision-making. Ensure effective communication and coordination between QC and other departments to streamline workflows and resolve issues in a timely manner. Represent the company during external audits and inspections, ensuring that QC practices are appropriately showcased. Training & Development: Develop training programs for QC personnel to ensure they are equipped with the necessary knowledge and skills to perform their duties effectively. Stay abreast of new developments in the pharmaceutical industry and injectables, and integrate relevant advancements into the QC strategy.