5.0 - 9.0 years

0 Lacs

hyderabad, telangana

On-site

The QA Technical Senior Associate plays a crucial role in supporting Quality Assurance initiatives within the Quality Operations Network, focusing on Technical Writing, Document Management, and Business Performance. In this position, you will be responsible for executing key QA documentation processes, coordinating systems, and performing project-related administrative functions to ensure compliance with Quality Management System (QMS) requirements and enhance operational efficiency. Your role will involve working during regular business hours to assist Amgen in fulfilling its mission of serving patients, potentially leading a shift-based team that provides coverage across various time zones. You may be required to work outside standard hours to meet business needs and determine the same for your team. This position is based in our office in Hyderabad, India (Amgen India-AIN), and will involve leading remote support from AIN to Amgen sites globally. Your responsibilities will include: - Managing requests for site licenses and country-specific reports - Drafting and managing workflows for QA-owned procedures, including Standard Operating Procedures (SOPs) and Appendices - Conducting periodic document reviews and providing document system support using tools like DocuSign and Kneat - Creating and maintaining Smartsheet trackers and dashboards to support quality and business operations - Providing project coordination and administrative support for various activities, such as invoicing, expense reporting, audit logistics, and travel arrangements Preferred qualifications for this role include: - Experience in a GMP or regulated environment with exposure to quality documentation systems and tools - Strong attention to detail and demonstrated skills in document drafting and editing - Proficiency in document and project management systems like DocuSign, Kneat, and Smartsheet - Effective organizational and time management abilities to handle multiple priorities - Strong communication and interpersonal skills for cross-functional coordination - Ability to work independently within defined parameters and follow established procedures Key competencies for this position encompass: - Technical Writing and Document Control - System and Workflow Coordination - Business Operations and Project Support - Cross-Functional Communication and Collaboration - Organizational Agility - Detail-Oriented Execution Basic qualifications required for this role include a Masters degree with 5-9 years of experience in Pharma and Biotech commercial or clinical manufacturing Quality.,

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