Senior Associate Quality Assurance - Global Supply Quality

7-9 years

Not Disclosed

Hyderabad

10 Dec. 27, 2024

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Associate Quality Assurance - Global Supply Quality

Location: Not specified
Company: Amgen

About Amgen:

Amgen is a global biotechnology leader dedicated to fighting serious diseases. With a focus on four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Diseases—Amgen has been helping millions of patients since 1980. Amgen is at the forefront of research, manufacturing, and delivering innovative medicines that improve the quality of life for individuals living with serious conditions.

Role Overview:

The Senior Associate Quality Assurance - Global Supply Quality will be responsible for overseeing the quality and compliance of suppliers and service providers. You will work closely with cross-functional teams to ensure compliance with Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and other regulatory requirements. This role involves managing supplier master data, preparing and reviewing SOPs, collaborating on operational improvements, and supporting audits and inspections.

Key Responsibilities:

Transactional Activities: Manage raw material and vendor master data in the enterprise resource planning (ERP) system, and oversee other tasks related to Audit Management, Supplier Change Notifications, training support, etc.
Compliance Oversight: Ensure compliance with GMP/GDP standards, preparing, reviewing, and approving SOPs and GMP/GDP documentation in alignment with regulatory requirements.
Collaboration: Work closely with internal teams and external partners to identify opportunities for process improvements, leveraging digital tools and AI for enhanced efficiency.
Risk Management: Incorporate risk management strategies into the supplier and service provider lifecycle, ensuring effective supplier monitoring and oversight.
Support for Audits: Assist in audit and inspection preparations, providing support for internal and external assessments.
Continuous Improvement: Participate in operational improvement initiatives, supporting projects that drive efficiency and align with business objectives.
Performance Management: Monitor and report on supplier performance metrics, ensuring healthy relationships with suppliers and service providers.
Autonomous Work: Operate independently, adhering to Amgen's values and leadership principles.

Basic Qualifications:

Master’s degree with 1 to 3 years of professional experience in related fields, OR
Bachelor’s degree with 3 to 5 years of professional experience in related fields, OR
Diploma with 7 to 9 years of professional experience in related fields.

Preferred Qualifications:

Experience with ERP systems (e.g., SAP) and Vendor Master Data.
Knowledge of GMP/GDP requirements and pharmaceutical regulations.
Experience in continuous improvement and lean practices.
Understanding of supply chain business processes, from end to end.
Project management experience across multiple departments and regions.
Strong analytical and problem-solving skills.
Ability to work autonomously under pressure and in teams.
Change management expertise.
Proficiency with Microsoft Office tools (Excel, Word, PowerPoint).
Effective written and verbal communication skills.
Familiarity with managing suppliers and service providers.

What You Can Expect from Us:

Amgen offers a collaborative culture and competitive benefits. We provide comprehensive Total Rewards plans that align with industry standards and support your career growth.

Interested in making a meaningful impact on patient care while advancing your career? Apply now to be part of the Amgen team.

Equal Opportunity Statement:

Amgen is an Equal Opportunity Employer. We welcome applications from all qualified individuals regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status, or any other protected characteristic.

For more details or to apply, visit careers.amgen.com

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Senior Associate Quality Assurance - Global Supply Quality

Job Description

Job Title: Senior Associate Quality Assurance - Global Supply Quality

About Amgen:

Role Overview:

Key Responsibilities:

Basic Qualifications:

Preferred Qualifications:

What You Can Expect from Us:

Equal Opportunity Statement:

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