Quality Associate - GMP & DI Compliance

Lonza Group Ltd.; Haryana; On-site; INR 900,000 - 1,300,000; Full time

Benefits offered by this job

Agile culture

Inclusive workplace

Performance-based compensation

Global cross-functional collaboration

Ongoing learning & development

Global benefits

Job summary

Lonza Group Ltd. is seeking an Associate – QMS & Compliance to strengthen the Quality Management System and ensure regulatory, customer, and internal quality requirements are met at the Rewari site in Haryana, India.

The role involves audits, vendor qualification, data integrity, document management, training programs, and continuous improvement initiatives, collaborating with Quality, Manufacturing, Supply Chain, Engineering, and Regulatory teams to maintain a strong quality culture.

Qualifications

• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related discipline.
• Experience in Quality Assurance, Quality Management Systems, Compliance, or regulated manufacturing environments.
• Strong understanding of GMP principles, quality systems, regulatory requirements, and compliance expectations.
• Knowledge of audit management, vendor qualification, document control, change management, CAPA, and data integrity practices.
• Experience working with Document Management Systems (DMS) and quality management processes.
• Excellent communication and stakeholder management skills across functions.

Responsibilities

• Ensure regulatory and customer requirements, Halal standards, and internal quality procedures are followed.
• Coordinate regulatory inspections, customer audits, certification audits, and follow-up actions.
• Maintain Approved Vendor List and support vendor qualification activities.
• Plan and coordinate vendor audits for compliance and improvements.
• Develop and monitor training programs for GMP and quality competency.
• Administer the Document Management System and ensure document control across the site.
• Lead self-inspection programs to identify gaps and drive corrective actions.
• Develop and improve Data Integrity Program and Data Integrity Matrix.
• Participate in Change Control with risk assessment and proper documentation.

Skills

Quality Assurance

GMP

Audits

CAPA

Data integrity

Document control

Vendor qualification

Regulatory inspections

Education

Bachelor’s or Master’s degree in Pharmacy or Life Sciences

Tools

DMS (Document Management System)

Quality management software

Job description

Location: Rewari, Haryana, India

We are seeking an Associate – QMS & Compliance to strengthen and maintain the Quality Management System (QMS) and ensure compliance with regulatory, customer, and internal quality requirements. This role is responsible for supporting audits, inspections, vendor qualification, data integrity, document management, training programs, and continuous improvement initiatives across the site. Working closely with Quality, Manufacturing, Supply Chain, Engineering, and Regulatory stakeholders, you will help maintain a robust quality culture by driving compliance, supporting risk-based quality processes, and ensuring adherence to applicable standards and regulations.

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

• Ensure compliance with applicable regulatory requirements, customer expectations, Halal standards, and internal quality procedures.
• Coordinate and support regulatory inspections, customer audits, certification audits, and follow-up actions to ensure successful outcomes.
• Maintain and manage the Approved Vendor List and support vendor qualification activities in accordance with quality and compliance standards.
• Plan, perform, and coordinate vendor audits to evaluate compliance and identify opportunities for improvement.
• Develop, implement, and monitor training programs to ensure personnel competency and compliance with GMP and quality requirements.
• Administer the Document Management System (DMS) and ensure effective document control practices across the site.
• Lead and execute self-inspection programs to identify compliance gaps and drive corrective and preventive actions.
• Develop, monitor, and continuously improve the site Data Integrity Program and Data Integrity Matrix across systems and processes.
• Participate in and manage Change Control activities, ensuring appropriate risk assessment, documentation, and implementation.

What we are looking for

• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related scientific discipline.
• Experience within Quality Assurance, Quality Management Systems, Compliance, or regulated manufacturing environments.
• Strong understanding of GMP principles, quality systems, regulatory requirements, and compliance expectations.
• Knowledge of audit management, vendor qualification, document control, change management, CAPA, and data integrity practices.
• Experience working with Document Management Systems (DMS) and quality management processes.
• Strong analytical and problem-solving skills with the ability to identify risks and drive effective corrective actions.
• Excellent communication and stakeholder management skills with the ability to collaborate across functions.

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.