Quality Associate - GMP & Data Integrity Compliance

Role Overview

Based in Rewari, Haryana, this position aims to reinforce and uphold the Quality Management System (QMS), ensuring adherence to regulatory, customer, and internal quality guidelines. The role demands active involvement in audits, inspections, vendor validation, document management, training, and continuous enhancement activities at the facility.

Key Responsibilities

• Ensure adherence to relevant regulatory mandates, customer requirements, Halal standards, and internal protocols.
• Organize and assist in regulatory inspections, customer audits, certification reviews, and handle subsequent corrective tasks for successful completion.
• Manage the Approved Vendor List and assist vendor qualification processes as per quality and compliance norms.
• Plan and execute vendor audits to assess compliance levels and identify improvement areas.
• Develop, implement, and oversee training programs to maintain staff competence in GMP and quality standards.
• Administer Document Management System (DMS), promoting effective document control throughout the site.
• Lead self-inspection initiatives to detect compliance gaps and coordinate corrective and preventive measures.
• Develop, track, and enhance the Data Integrity Program and Matrix across systems and processes.
• Participate in Change Control activities, ensuring proper risk evaluation, documentation, and execution.

Candidate Profile

• Possess a Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related scientific field.
• Experience in Quality Assurance, Quality Management Systems, Compliance, or regulated manufacturing sectors.
• Thorough understanding of GMP guidelines, quality frameworks, regulatory requirements, and compliance standards.
• Familiarity with audit handling, vendor qualification, document control, change management, CAPA, and data integrity practices.
• Proficiency with Document Management Systems (DMS) and quality management workflows.
• Strong analytical and problem-solving capabilities to detect risks and implement corrective actions.
• Excellent communication and stakeholder collaboration skills across functional teams.

About the Employer

Lonza is a global life sciences leader with over 30 sites across five continents, driven by core values of Collaboration, Accountability, Excellence, Passion, and Integrity. The company fosters innovation by embracing diverse perspectives and promotes an inclusive and ethical workplace culture. Lonza offers a dynamic working environment emphasizing career agility, competitive compensation, and continual professional development.

What the Role Offers

• A cutting-edge and adaptable career environment.
• An inclusive, ethical workplace culture.
• Reward programs acknowledging exceptional performance.
• Opportunities for cross-functional collaboration worldwide.
• Continuous learning and growth prospects.

Reference Number

R77753