QA Specialist, QC and Laboratory Equipment Qualification

QA Specialist, QC and Laboratory Equipment Qualification

Location

The actual location of this job is in Hyderabad, India.

Relocation assistance is available for eligible candidates and their families, if needed.

Join our team in Hyderabad to drive quality compliance and data integrity across cutting-edge QC laboratory equipment, directly enabling the manufacturing of life-changing therapies worldwide.

Working Model

This is an office‑first role. Working together in person supports close, real‑time collaboration and team alignment, enabling us to deliver our best work. You will work primarily in the office, with the flexibility to work remotely for 20% of your time (Three days from Office).

What You Will Get

• An agile career and dynamic working culture.

• An inclusive and ethical workplace.

• Compensation programs that recognize high performance.

• A variety of benefits dependent on role and location.

The full list of our global benefits can be found here: https://www.lonza.com/careers/benefits.

What You Will Do

• Provide QA Oversight: Lead QA governance for QC and laboratory equipment qualification activities in compliance with Lonza procedures, cGxP requirements, and data integrity standards.

• Review & Approve Documentation: Review and approve full qualification lifecycle documentation, including risk assessments, qualification protocols, reports, deviations, CAPAs, and change controls.

• Ensure Technical & Scientific Integrity: Ensure all qualification activities are scientifically sound, properly documented, and executed according to approved procedures.

• Guide Execution & Resolve Discrepancies: Support real-time qualification execution by providing QA guidance and overseeing the resolution of deviations, discrepancies, and quality events.

• Manage Equipment Lifecycle: Maintain equipment compliance through qualification, requalification, change impact assessments, and inspection readiness.

• Collaborate with Stakeholders: Serve as the QA representative collaborating cross-functionally with QC / Lab Operations, Validation SMEs, and Automation/CSV Engineers.

• Drive Process Improvement: Identify compliance risks and drive continuous improvement across qualification documentation standards, risk-based solutions, and data integrity practices.

What We Are Looking For

• Education: Bachelor’s or Master’s degree in a Science-related discipline or Engineering.

• Experience: 5–10 years of experience in pharmaceutical or biotech GMP Quality, QC laboratory operations, equipment qualification, or related technical compliance roles.

• Qualification Lifecycle Expertise: Practical knowledge of laboratory equipment qualification stages (URS, risk assessment, IQ/OQ/PQ, requalification, periodic review, and change assessment).

• Quality & Compliance Proficiency: Solid understanding of cGxP, GDocP/cGDP, data integrity principles, and regulatory expectations for GMP laboratories.

• Document & Quality Event Review: Proven background reviewing or approving qualification protocols, executed records, deviations, CAPAs, and root cause investigations.

• Skills & Approach: Meticulous and analytical mindset with strong written/oral communication skills in English and the ability to manage parallel priorities.

• Preferred Qualifications: Specialized training or certifications in GMP qualification/validation, data integrity, internal auditing, or Lean/Continuous Improvement.

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.