QA Specialist, QC and Laboratory Equipment Qualification

Overview

QA Specialist supporting QC and laboratory equipment qualification, ensuring GMP compliance, data integrity and operational excellence within Lonza's global Quality organization.

What you'll do

• Provide Quality Assurance oversight for QC and laboratory equipment qualification activities, ensuring compliance with GMP, data integrity, and regulatory requirements.
• Review and approve qualification documentation including risk assessments, protocols, reports, deviations, CAPAs, change controls, and periodic reviews.
• Support equipment lifecycle management activities including qualification, requalification, change assessments, and inspection readiness.
• Partner with QC laboratories, Validation & Qualification SMEs, Automation/CSV Engineers, Engineering, and Quality teams to ensure robust qualification practices.
• Provide QA guidance during qualification execution and ensure appropriate management of quality events and deviations.
• Identify compliance risks and drive continuous improvement initiatives that strengthen qualification processes, documentation standards, and data integrity practices.
• Serve as a subject matter expert and independent quality contributor supporting global qualification and quality excellence programs.

What you'll need

• Bachelor's or Master's degree in a science-related discipline or engineering field.
• Experience in pharmaceutical, biotechnology, GMP Quality, QC laboratory operations, validation, qualification, or technical compliance environments.
• Strong understanding of QC laboratory workflows and the role of qualified laboratory equipment in generating reliable GMP data.
• Practical experience across the equipment qualification lifecycle including URS, risk assessments, IQ/OQ/PQ, requalification, periodic reviews, and change impact assessments.
• Knowledge of cGxP, GMP documentation practices, GDocP/cGDP requirements, and data integrity principles.
• Strong analytical, documentation review, communication, and stakeholder management skills.
• Ability to work independently, manage multiple priorities, and contribute to continuous improvement initiatives in a highly regulated environment.

Details

• Location: Hyderabad, India; role is primarily based on site.
• Remote work permitted for no more than 20% of time, considered case by case in line with business needs.
• Relocation assistance is available for eligible candidates and their families, if needed.