Solution Architect, Validation (Bengaluru)

Solution Architect, Validation (Bengaluru)

03 Oct
|
West Pharmaceutical Services
|
Bengaluru

03 Oct

West Pharmaceutical Services

Bengaluru

Description

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier setting and planet through our sustainability efforts.

Job Summary

In this role,



you will be responsible for handling various computer system validation activities for different cross functional programs across West Pharma.

Essential Duties And Responsibilities

• Lead and execute validation activities for GxP computerized systems in compliance with global regulatory requirements (FDA, EU Annex 11, GAMP 5, CSA).
• Perform system impact assessments and risk assessments to define appropriate validation scope and strategy.
• Author, review, and execute validation deliverables (VP, URS, RA, IQ/OQ/PQ, RTM, VSR).
• Demonstrate strong understanding of computerized systems, their intended use, data flows, and system lifecycle to ensure appropriate validation controls are established.
• Guide cross-functional teams (QA, IT, Engineering, Manufacturing, Vendors) to ensure validation requirements are properly integrated during system implementation and changes.
• Ensure compliance with Data Integrity (ALCOA+) pri

📌 Solution Architect, Validation (Bengaluru)
🏢 West Pharmaceutical Services
📍 Bengaluru

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