Career Category Quality QA Technical Specialist The AIN QA Technical Specialist plays a critical role in advancing Quality Assurance initiatives across the Quality Operations Network with a particular focus on Management Review Inspections and Compliance and Technical Writing Data Analytics This role provides operational support technical leadership and cross-functional collaboration to ensure compliance continuous improvement and data-driven decision making in support of the Quality Management System QMS The position will be responsible for tasks including the key responsibilities documented below and other technical quality-related job functions This candidate will primarily work during regular working hours 9 AM - 6 PM local time to enable the business in delivering Amgen s mission to serve patients and may lead a shift-based team that provides coverage in support of the Amgen network across multiple time zones The candidate may need to work outside of his her routine workday to support business needs and will be responsible for determining the same for their staff The individual will be required to work from our office located in Hyderabad India Amgen India-AIN The candidate will also lead the remote support from AIN to Amgen sites globally Key Responsibilities - Management Review Coordinate and manage all logistics related to Site Management Review including compiling metrics maintaining and updating Smartsheet trackers and preparing content Perform site-level and cross-site trend analysis as applicable using key quality metrics identify trends and collaborate with site stakeholders to implement corrective and preventive actions CAPA Lead preparation of Management Review meetings ensuring comprehensive data presentation creation documentation of meeting minutes and follow-up on action items Inspections and Compliance Support readiness and response for internal and external inspections including generation of pre-inspection documents such as deviation lists chan