Quality Engineering, QA Specialist, Document Lifecycle

Quality Engineering, QA Specialist – Document Lifecycle

Location: Hyderabad, India

As a QA Specialist in Document Lifecycle, you will play a critical role in ensuring the integrity, standardization, and optimization of documentation across Lonza’s global engineering and CAPEX projects. This position supports inspection readiness, compliance activities, and the continuous improvement of document management processes. By driving harmonization of standards and supporting audits, you will help maintain Lonza’s commitment to quality excellence and regulatory compliance.

• Documentation Management: Create, maintain, and optimize documentation across electronic platforms (TrackWise, Kneat, DMS) to support CAPEX projects and global procedures.

• Standardization & Optimization: Drive harmonization of global standards, processes, templates, and protocols to ensure consistency and efficiency.

• Audit & Inspection Support: Assist inspection preparation and auditing teams by providing summarized data, reports, and compliance oversight.

• Quality Assurance Reviews: Conduct QA reviews of global engineering standards and documents, ensuring adherence to Lonza’s quality principles and GMP regulations.

• Compliance Activities: Support senior team members in enforcing compliance with global standards and procedures, reporting compliance status, and contributing to CAPA activities.

• Data Integrity: Uphold Lonza’s data integrity policies by proactively evaluating and improving documentation processes.

• Commissioning & Qualification (C&Q): Contribute to the development and implementation of quality system standards for commissioning and qualification activities.

• Continuous Improvement: Identify opportunities to enhance document lifecycle processes and support global engineering initiatives.

• Miscellaneous Support: Assist with regulatory reports, monthly updates, and quarterly inspection reports as required.

Education & Experience

• Bachelor’s degree (or equivalent) in Engineering (Biologics or Chemical preferred).

• Experience in document management systems and QA processes within a regulated environment.

• Familiarity with GMP regulations and global quality standards.

Skills & Attributes

• Strong organizational and documentation skills with attention to detail.

• Ability to work collaboratively with global engineering leads, regional QA teams, and project delivery teams.

• Analytical mindset with a proactive approach to compliance and process improvement.

• Business fluent in English.

At Lonza, quality is at the heart of everything we do. Our teams across the globe work together to ensure that the medicines of tomorrow are manufactured to the highest standards. Guided by our values—Collaboration, Accountability, Excellence, Passion, and Integrity—we foster innovation and continuous improvement. By joining Lonza, you will contribute to shaping a safer, more compliant future in life sciences.