Assistant Manager
CurrentKey Responsibilities:•Conduct comprehensive audits of various manufacturing sites, including hormonal, oncology (onco), oral solid dosage (OSD), topical, cosmetic, food, and parenteral formulations, ensuring strict adherence to quality and safety standards.•Oversee the approval process for new products, ensuring they meet rigorous quality benchmarks before production.•Investigate and resolve market complaints, managing Out of Specification (OOS), Out of Trend (OOT), and deviation events through root cause analysis and efficient corrective and preventive actions (CAPA).•Lead the execution of product record data reviews to maintain accuracy and integrity in documentation.•Develop and conduct targeted training programs for manufacturing sites, emphasizing quality assurance processes and continuous improvement initiatives.•Execute witness analysis and testing data reviews to ensure the integrity of product testing and quality assurance practices.•Implement and oversee Poka Yoke (error-proofing) systems to minimize defects and improve process reliability at manufacturing sites.•Utilize Quality Modelling (Q-mod) methodologies and On-Page Quality Reviews to enhance documentation accuracy and process effectiveness.•Manage the T3Z process for thorough reviewing of quality parameters and site performance.•Regularly conduct depot visits to verify storage practices, distribution processes, and compliance with established quality standards.•Collaborate with cross-functional teams to optimize quality assurance protocols and contribute to the overall success of products.Key Achievements:•Successfully led numerous audits across diverse product categories, resulting in improved compliance and a significant reduction in non-conformance incidents.•Instrumental in the successful launch of several new product lines, ensuring adherence to rigorous quality standards throughout the process.
