About this role
Location: Hyderabad, India
Join Lonza’s Global Capability Center (GCC) in Hyderabad and support global external manufacturing quality operations. As a Quality Operations Specialist, you will perform detailed review of GMP batch documentation from CDMO partners, ensuring compliance with Lonza quality standards, regulatory requirements, and data integrity principles.
What you will get
An agile career and dynamic working culture.
An inclusive and ethical workplace.
Compensation programs that recognize high performance.
Opportunities to collaborate with global cross-functional teams.
Ongoing learning and professional development opportunities.
Our full list of global benefits can be found here: https://www.lonza.com/careers/benefits.
What you will do
Review external GMP batch documentation from CDMO partners for completeness, accuracy, and compliance with approved manufacturing and regulatory requirements.
Evaluate analytical data, Certificates of Analysis (CoA), and laboratory documentation to ensure data integrity and GMP compliance.
Support Quality oversight of external manufacturing activities, including preparation for batch disposition.
Identify documentation inconsistencies, deviations, and potential compliance risks, ensuring timely escalation to Quality stakeholders.
Collaborate with internal teams (QA, QC, Supply Chain) and external CDMO partners to resolve documentation queries and ensure alignment.
Generate and maintain Key Quality Indicators (KQIs) to monitor external manufacturing quality performance.
Ensure adherence to Lonza Quality Standards, data integrity principles, and global/local GMP regulations.
What we are looking for
Bachelor’s degree in Chemistry, Biotechnology, Pharmaceutical Sciences, or related field.
Experience in GMP-regulated pharmaceutical, biopharmaceutical, or CDMO environments is advantageous.
Understanding of GMP documentation, batch records, and data integrity requirements.
Strong attention to detail with the ability to review complex documentation accurately.
Effective communication skills with business fluency in English.
Ability to work cross-functionally with internal teams and external partners.
Organized, proactive, and able to manage multiple priorities in a fast-paced environment.
About Lonza
At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.
Ready to shape the future of life sciences? Apply now.
About Lonza
Swiss contract development and manufacturing organization (CDMO) providing biologics, cell, and gene therapy production services.
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