Summary
Location
Bengaluru
Type
full-time
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About this role
Your Role: As a Quality Validation Expert, you will be responsible for identifying, planning, and implementing validation requirements in a cGMP environment. This includes overseeing cleanroom, equipment, instruments, and manufacturing/testing processes in a Green Field Pharma facility. You will prepare and execute IQ/OQ/PQ protocols, coordinate computer system validation, and ensure compliance with applicable standards.
Who You Are:
Minimum Requirements:
- Master of Science (Life Science) from a reputed institution.
- Minimum of 8 years of experience, with at least 5 years in quality assurance within reputed pharmaceutical industries or research institutes.
Maximum Requirements:
- Develop and maintain the validation master plan (VMP).
- Conduct risk assessments and ensure compliance with cGMP, GAMP 5, and FDA regulations.Collaborate with Quality, Production, Engineering, and IT teams to drive validation and quality assurance deliverables.
- Participate in internal and external audits and respond to findings related to validation.
Other facts
About Merck Life Science Private Limited
Together with our colleagues, customers and stakeholders, we impact life and health with science. Before researchers can make scientific breakthroughs, they must have access to state-of-the-art tools, services and expertise to perform experiments and engineer new products. That’s where we come in.
We offer one of the broadest portfolios in the industry for scientists, best-in-class products for pharmaceutical development and manufacturing, and a fully integrated service organization to support CDMO and contract testing across traditional and novel modalities.
Our vision is a world where our innovative products, services and digital offerings help create solutions for people globally and a sustainable future for generations to come.
Merck is a global science and technology company with around 60,000 employees in more than 66 countries.
Not intended for US & CA visitors.
What you'll do
- As a Quality Validation Expert, you will identify, plan, and implement validation requirements in a cGMP environment. This includes overseeing cleanroom, equipment, instruments, and manufacturing/testing processes.
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