Lonza
Quality Engineering, QA Specialist, Single Use and Supplier Quality
Location: Hyderabad, India
Job Description Summary:This role exists to ensure compliance with cGMP and global regulatory requirements by providing first level support on quality guidance and oversight for Single Use Systems (SUS) across Lonza’s manufacturing network. As part of the global QA team, the position supports strategy, execution, and implementation of SUS standards, ensuring alignment with established global quality frameworks. The QA Specialist provides technical expertise, risk management, and documentation support, while supporting audits, inspections, and CAPEX projects.
Key Accountabilities:SUA Qualification: Draft and review URS (User Requirement Specification) and QR (Qualification Report) documents for Single Use Assemblies.
Global Alignment: Collaborate with Global Engineering C&Q/CSV and GQE Internal Teams to harmonize commissioning and qualification standards.
Supplier Qualification: Coordinate support for supplier qualification processes in growth projects; support process revisions, implementation, and roll‑out into new regions.
Compliance Oversight: Support senior team members in conducting internal GE compliance activities and enforce adherence to global standards and procedures on CAPEX projects.
QA Reviews & Approvals: Responsible for QA review and approval of global engineering standards and documents.
Data Integrity: Uphold Lonza’s data integrity principles; proactively evaluate, identify, and improve data integrity processes.
Documentation & Governance: Review and approve technical documentation, risk assessments, regulatory responses, and global QMS documents related to SUS and raw materials.
Audit & Inspection Support: Contribute to audits, inspections, and process qualification activities; support CAPEX project teams in preparation for inspections.
Vendor Assessment: Assess vendor change notifications (VCNs); contribute to global training initiatives and best practices.
Other Duties: Perform additional tasks as assigned, including regulatory CAPA reports, monthly updates, and quarterly inspection reports.
Strong knowledge of cGMP and regulatory requirements (e.g., FDA, Swissmedic).
Acumen in Single Use Systems and raw material management.
Ability to assess risk and provide technical guidance on deviations, CAPAs, and change controls.
Strong stakeholder management and collaboration skills across global teams.
Excellent organizational, documentation, and reporting abilities.
Experience with supplier qualification, engineering standards, and CAPEX project compliance.
High attention to detail and commitment to quality standards.
Bachelor’s or Master’s degree in Life Sciences, Engineering, or related field.
0–4 years of experience in Quality Assurance within pharmaceutical or biotech manufacturing.
Experience in SUS qualification, regulatory compliance, and global QA environments.
Familiarity with QMS systems and industry technical forums.
About Lonza
At Lonza, our people are our greatest strength. With more than 30 sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values—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. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. Lonza is committed to creating an inclusive environment for all employees.