8.0 - 12.0 years

0 Lacs

hyderabad, telangana

On-site

As an AIN Specialist QA at Amgen, you play a critical role in supporting product disposition tasks across the Quality Operations Network. Leveraging your industry, technical, and quality systems knowledge, you ensure efficient management of product expiry processes, product complaints, disposition manager training, and fulfillment of related data requests. Your responsibilities include executing GMP processes for shelf-life extension, supporting partner requests for data related to partnered product batches, generating Certificate of Analysis records, providing training to new disposition managers, and conducting full batch record reviews for product complaints. You will primarily work during regular hours to assist in delivering Amgen's mission of serving patients and may lead a team providing coverage across multiple time zones. Flexibility to work outside regular hours and from the office in Hyderabad, India, is required. Moreover, you will lead remote support to Amgen sites globally. Key responsibilities also involve extending expiration dates for products, updating batch information in the SAP inventory system, evaluating expiry-SAF forms, supporting partner requests for data recovery, generating COAs, providing training to new managers, and conducting batch record reviews for product complaints. Preferred qualifications for this role include experience in project management, proficiency in technical writing and data visualization tools, excellent communication skills, ability to lead cross-functional teams, and experience in manufacturing environments. Core competencies required include working in a regulated environment with knowledge of GMP and GDP requirements, familiarity with Quality Systems such as ERP/SAP, RIM, CDOCS, QMTS, DQMS, and LIMS, staff training experience, and technical document drafting. The basic qualifications for this position include a Master's degree with 8-12 years of experience in Pharma and Biotech commercial or clinical manufacturing Quality. If you are passionate about making a lasting impact on patients" lives through innovative medicines and are eager to contribute to a collaborative and science-based culture, join us at Amgen and transform your career while transforming the lives of patients.,

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