Manager Quality Assurance

As a Manager Quality Assurance at Syngene International Ltd., you will be responsible for ensuring compliance with all national and international regulatory agency requirements related to API manufacturing. Your role will involve evaluating and approving vendors/subcontractors, reviewing and approving various reports such as SOP, analytical method validation, and calibration reports, and coordinating review meetings to maintain the effectiveness of the quality system. You will be expected to have a strong understanding of regulatory requirements from agencies such as ICH, USFDA, WHO Geneva, PMDA Japan, and others. Additionally, you will play a key role in the approval of protocols and reports related to qualification and validations of facilities, equipment, and utilities within the manufacturing facility and warehouse. In this role, you will also be responsible for releasing or rejecting raw materials, intermediates, finished products, and packaging materials, as well as overseeing end-to-end activities of document control and archival at the site. Furthermore, you will need to ensure the availability of resources within the specified budget and support the Department Head in budget preparation. Key responsibilities of this position include maintaining a robust Quality Management System (QMS) in compliance with regulatory requirements, managing responses to regulatory inspections and audits, and providing training programs for QA personnel. You will also be responsible for promoting a culture of quality and compliance throughout the organization, ensuring data integrity compliance, and conducting self-inspections to keep manufacturing operations audit-ready at all times. To excel in this role, you should possess good communication skills and have experience in the API industry. Additionally, you should demonstrate strong commitment to work, dedication, enthusiasm, and persuasive ability within a team environment. Attention to detail, proactive approach, ability to work in a dynamic environment, meet tight deadlines, and prioritize workloads are essential for success in this position. Being able to develop creative solutions, work effectively in a team, and show flexibility in working shifts are also key attributes required for this role.,