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Amgen
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Senior Associate Quality Assurance - Global Supply Quality

Senior Associate Quality Assurance - Global Supply Quality

Amgen

1 - 3 years

9 - 13 Lacs

Hyderabad

Posted:6 days ago| Platform:

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Skills Required

Supply chain Change management Technical writing Project management Pharma Analytical Risk management Raw material Monitoring Business operations

Work Mode

Work from Office

Job Type

Full Time

Job Description

Let s do this. Let s change the world. In this vital role you will The Sr. Associate QA position is responsible for the Quality and Compliance Oversight of Raw material suppliers. This position is responsible for being an integral quality member of the Amgen cross-functional raw materials suppliers team that includes but is not limited to business operations, analytical science, process development, and supply chain.

Responsibilities :

Working independently, the individual will be responsible for, but not limited to the following:

Perform QA Contact role on the Quality Events, Change Control records, Corrective and Preventive Actions, effectiveness verification and documentation
Work closely with all relevant stakeholders for the end-to-end process and ensure compliance to GMP/GDP.
Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations
Collaborate with raw material suppliers to ensure adherence to quality agreements, identifying performance improvement opportunities
Understand and incorporate risk management strategy into the overall raw material lifecycle
Provide support to the supplier periodic monitoring oversight activities
Support in tactical activities related to internal/external audits and inspections
Perform routine quality assessments and provide approval of changes to raw material inspection profiles
Take part in operational improvement initiatives, programs, and projects
Develop solutions that are thorough, practical, and consistent with functional objectives
Ownership of supplier metrics, performance assessments, and other key documents to inform the health of supplier relationships.
Work under minimal supervision in line with Amgen Values and Leadership Attributes.
This role may require working in shifts or extended hours within the same shift to support global timezones.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

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.
Familiarity with raw material compendial testing
Experience overseeing quality of suppliers or external parties
Strong technical writing skills

Preferred Qualifications:

Experience and strong familiarity with digital tools and computerized systems.
Strong continuous improvement approach 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.
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

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

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Senior Associate Quality Assurance - Global Supply Quality