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Senior Associate Quality Assurance - Global Supply Quality

2 - 6 years

2 - 6 Lacs

Posted:2 weeks ago| Platform: Foundit logo

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Work Mode

On-site

Job Type

Full Time

Job Description

In this vital role, you'll be responsible for the Quality and Compliance Oversight of supplier and service provider vendor master data for all operations. As an integral member of the Amgen Global Supply Quality team, you'll also ensure additional Quality System and business tool needs are met for the organization. Working independently, you will be responsible for, but not limited to, the following: Key Responsibilities Perform transactional activities related to raw material and vendor master data in the enterprise resource planning (ERP) system. Own transactional activities associated with other Global Supply Quality tasks (e.g., Audit Management System (AMS), Supplier Change Notification (SCN) Mailbox and records, training support, etc.). Work closely with all relevant key collaborators for the end-to-end process and ensure compliance with GMP/GDP. Prepare, review, and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, ensuring alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP), and other applicable regulations. Collaborate with internal key collaborators, identifying performance improvement opportunities and maximizing digital tools and AI for efficiencies. Understand and incorporate risk management strategy into the overall supplier and service provider lifecycle. Provide support to the supplier periodic monitoring oversight activities. Support tactical activities related to internal/external audits and inspections. Perform routine quality assessments and provide assessments of changes that impact master data. Take part in operational improvement initiatives, programs, and projects. Develop solutions that are detailed, practical, and consistent with functional objectives. Ownership of metrics, performance assessments, and other key documents to inform the health of supplier and service provider relationships. Work under minimal direction in line with Amgen Values and Leadership Attributes. What We Expect of You Basic Qualifications Master's degree and 1 to 3 years of professional experience in related fields OR Bachelor's degree and 3 to 5 years of professional experience in related fields OR Diploma and 7 to 9 years of professional experience in related fields Understanding of GMP/GDP requirements. Strong technical writing skills. Preferred Qualifications Experience with ERP (e.g., SAP) Systems and Vendor Master Data. Strong continuous improvement attitude and lean practices experience. Understanding of end-to-end supply chain business processes. Experience in project management across multiple departments and geographies. Quick process understanding, insight, and visualizing skills. Strong analytical and problem-solving skills. Independent self-starter, able to work autonomously, under pressure, and in teams. GMP/GDP knowledge and understanding of pharmaceutical regulations. Energetic, detail-oriented, highly motivated with a can-do outlook. Change management skills. Ability to communicate across all levels of the organization. Effective written and verbal communication skills. Experience with Microsoft Office Tools including Excel, Word, and PowerPoint. Ability to multi-task and prioritize. Familiarity with requirements of managing suppliers and service providers.

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