Senior Associate QA, International Distribution Quality

Amgen; India; On-site; INR 1,700,000 - 2,100,000; Full time

Job summary

Amgen in India is seeking a Senior Associate QA, International Distribution Quality, to join our global quality team. You will implement and oversee distribution and transportation from Amgen's Global Supply Hubs to markets worldwide, ensuring QA oversight and regulatory compliance.

You will work with cross-functional teams, manage QA events, change controls, and CAPAs, and support internal audits and supplier performance initiatives in a fast-paced biotechnology environment.

Qualifications

• Bachelor's degree in science or engineering.
• 7+ years of professional experience in related fields.
• Familiarity with GMP/GDP requirements.
• Familiarity with logistics processes of parcel, transport, and warehousing providers.
• Experience in Validation/Qualification of processes, equipment, and facilities.
• Strong technical writing skills.

Responsibilities

• Implement and oversee global product distribution and transportation from Global Supply Hubs to global markets.
• Provide QA oversight of QA activities for Global Supply Chain operations.
• Perform QA contact role on Quality Events, Change Controls, CAPAs, and investigations.
• Collaborate with internal teams and third parties to meet service levels and regulatory requirements.
• Ensure GMP/GDP compliance and oversight across distribution quality processes.
• Support internal/external audits and supplier performance initiatives.

Skills

GMP GDP knowledge

Logistics process understanding

Technical writing

Analytical thinking

Problem solving

Independent/self-starter

Education

Bachelor's degree in science or engineering

Job description

Career Category

Quality

Job Description

Join Amgen's Mission of Serving Patients

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.

Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Associate QA, International Distribution Quality

What you will do

We are seeking a highly motivated individual for our International Distribution Quality (IDQ) team. This is an incredibly exciting opportunity to join a team of quality professionals in global distribution team.

HOW MIGHT YOU DEFY IMAGINATION?

You've earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you've worked hard to acquire and the passion you already have. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this relevant role.

Role Description

The Sr. Associate QA position will implement and oversee global product distribution and transportation from Amgen's Global Supply Hubs to Amgen's global markets and provide QA oversight of QA activities for Global Supply Chain operations. This role may require working in shifts or extended hours within the same shift.

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, as well as QA triage of Distribution complaints.
• Work closely with all relevant collaborators for the end-to-end process and ensure compliance to GMP/GDP.
• Expertise in quality assessment associated with transport temperature excursion management.
• Expertise in assessing quality impacts of distribution deviations.
• Hands-on experience in internal audits or self-inspections.
• Demonstrated experience in batch disposition and release processes.
• Act as subject matter expert (SME) for transportation related Quality Processes.
• 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 the 3rd Parties to ensure adherence to service levels, identifying and implementing performance improvement
• Understand and incorporate risk management strategy into overall supply chain strategy
• Provide support for logistic service provider and transportation service provider oversight
• Support in tactical activities for internal/external audits and inspections as part of the audit/inspection team
• Provide quality expertise and guidance to operational staff and within cross functional Amgen teams
• 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

Basic Qualifications:

We are all different, yet we all use our unique contributions to serve patients. The quality professional we seek is a strong leader with these qualifications:

• Bachelor's degree in science or engineering and 7+ years of professional experience in related fields.
• Understanding of GMP/GDP requirements.
• Familiarity with logistics processes of parcel, transport, and warehousing providers.
• Experience in Validation/Qualification of processes, equipment, and facilities.
• Strong technical writing skills.

Preferred Qualifications:

• Global Supply Quality Background.
• Distribution Quality background.
• 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.
• Strong analytical and problem-solving skills.
• Independent self-starter, able to work autonomously, under pressure and