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Amgen
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Sr. Associate

Sr. Associate

Amgen

1 - 3 years

14 - 15 Lacs

Hyderabad

Posted:1 week ago| Platform:

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Skills Required

Supply chain Technical writing Pharma Analytical Project management Oncology Contract manufacturing GMP Troubleshooting Raw material

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 willbe serving patients through internal collaboration with Amgen s global quality teams, manufacturing sites and external engagement with contract manufacturing organisations. You will make key contributions to ensure high quality and right first time materials are received at the Amgen, build a resilient supply network and conclude with a positive patient experience.

In this role you will be part of Amgen s Global Supply Quality team supporting oversight and maintenance of contract manufacturers.

Roles & Responsibilities:

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

Enter analytical into LIMS

Create and update LIMS sample plans

Generate Certificate of Analysis

Compile batch release documentation

Perform QA Approver role on the Quality Events

Initiate Quality records for supplier related changes

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

Take part in operational and quality improvement initiatives, programs, and projects.

Communicate effectively with stakeholders, ensuring alignment on quality objectives and compliance needs.

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 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 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 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

Soft Skills:

Excellent analytical and troubleshooting skills.

Strong verbal and written communication skills

Ability to work effectively with global, virtual teams

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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Sr. Associate