QA Specialist, QC and Laboratory Equipment Qualification

Lonza Group Ltd.; Hyderabad; Hybrid; INR 800,000 - 1,400,000; Full time

Benefits offered by this job

Agile culture

Inclusive workplace

Global collaboration

Professional development

Role-based benefits

Job summary

Lonza Group Ltd. in Hyderabad, India, is seeking a QA Specialist to provide QA oversight for QC and laboratory equipment qualification activities, ensuring GMP compliance and data integrity.

You will review qualification documents and support lifecycle management across global teams, collaborating with QC, Validation, and Engineering to uphold quality excellence. The role emphasizes independent quality contribution, risk assessment, and continuous improvement in a highly regulated environment,

Qualifications

• Bachelor's or Master's degree in a science-related field or engineering.
• Experience in pharmaceutical/biotech GMP QC environments.
• Knowledge of QC laboratory workflows and qualification lifecycle (URS, risk assessments, IQ/OQ/PQ).
• Strong data integrity and GMP documentation practices.
• Excellent analytical and stakeholder management skills.

Responsibilities

• Provide QA oversight for QC and laboratory equipment qualification activities.
• Review and approve qualification documents 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.

Skills

Quality Assurance

GMP compliance

Data integrity

Documentation review

Stakeholder management

Education

Bachelor's or Master’s in science/engineering

Tools

IQ/OQ/PQ

Job description

QA Specialist, QC and Laboratory Equipment Qualification

Location: Hyderabad, India The actual location of this job is in Hyderabad, India. Relocation assistance is available for eligible candidates and their families, if needed. Every day, our teams across the world work together to turn scientific breakthroughs into life-changing medicines that reach up to 100 million patients a year. Lonza is a place where people can make a unique impact, grow their careers and belong. Join Lonza's global Quality organization and play a critical role in ensuring that QC laboratory equipment qualification activities meet the highest standards of GMP compliance, data integrity, and operational excellence. This role offers the opportunity to collaborate with international stakeholders while supporting innovative quality and qualification initiatives across Lonza's global network. This role is primarily based on site. Working together in person supports close, real-time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards. We offer flexibility to work remotely for no more than 20% of your time. Requests are considered on a case-by-case basis, in line with business needs.

What you will get:

• An agile career and dynamic working culture.
• An inclusive and ethical workplace.
• Compensation programs that recognize high performance.
• Opportunities to work with global quality, validation, and laboratory experts.
• Exposure to innovative laboratory technologies and qualification programs.
• Continuous learning and professional development opportunities.
• 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 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 we are looking for:

• 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.

You will feel at home at Lonza if:

• Take ownership, step forward, and enjoy meaningful responsibility.
• Love solving problems and thrive in a complex, fast-moving environment.
• Are curious, always looking to learn and improve.
• Work collaboratively, contributing to something bigger than yourself.
• Are motivated to make a difference through work that impacts customers and their patients.

Why Lonza:

We are a place of unique opportunity, where your ideas, expertise and ambition can make a real difference. Here, you will have the freedom to grow, the support to succeed and the chance to contribute to work that matters. Join us. Be you. We are the makers of the medicines of tomorrow. Join us. Be you.