Quality Engineering, QA Specialist, Project Delivery (CQ & CSV)

Quality Engineering, QA Expert – Project Delivery (CQ & CSV)
Location: Hyderabad, India

Job Summary:
As a QA Expert in Project Delivery, you will ensure qualification and validation compliance of equipment and computerized systems used in cGMP pharmaceutical manufacturing. This role provides quality guidance to project teams, translates regulatory requirements into actionable strategies, and represents Global QA in cross-functional initiatives. By overseeing commissioning, qualification, and validation activities, you will safeguard Lonza’s adherence to global quality standards and regulatory expectations while driving consistency across CAPEX projects.

Key Responsibilities:

• Qualification & Validation Compliance: Ensure qualification and validation plans for equipment and computerized systems meet Lonza’s quality standards and regulatory requirements. Review and approve commissioning, qualification, and validation protocols and reports.
• Regulatory & Compliance Oversight: Provide guidance on cGMP and regulatory requirements (e.g., FDA, Swissmedic), assessing the impact of new or revised regulations on project delivery.
• Global QA Representation: Act as the voice of Global QA in cross-functional teams, ensuring quality compliance and alignment with Lonza’s global engineering standards.
• Project Quality Reviews: Support execution of Project Quality Reviews (PQRs) and contribute to internal audits across CAPEX projects to maintain compliance consistency.
• Documentation & Audits: Review and approve technical documentation, risk assessments, and regulatory responses. Support inspection readiness and audit activities for growth projects.
• Data Integrity: Uphold Lonza’s data integrity principles by proactively evaluating, identifying, and improving processes.
• Continuous Improvement: Translate regulatory trends and inspection outcomes into actionable quality improvements for CAPEX projects.
• Collaboration: Work closely with Global Quality Engineering Project Delivery and internal teams to harmonize commissioning and qualification standards.
• Other Duties: Perform additional tasks as required to support senior team members and project delivery.

Key Requirements
 

Education & Experience

• Bachelor’s or Master’s degree in Engineering (Biologics or Chemical) or Biological Sciences.
• Strong background in qualification, validation, and compliance within a regulated pharmaceutical environment.
• Experience with GMP regulations and global quality standards.

Skills & Attributes

• Solid understanding of commissioning, qualification, and validation processes for equipment and computerized systems.
• Strong analytical and problem-solving skills with a proactive approach to compliance and risk management.
• Excellent communication and stakeholder management skills, with the ability to represent QA in cross-functional teams.
• Business fluent in English.

Key Stakeholders

• Global Engineering Leads
• Regional QA Teams
• Project Delivery Team Members

Supervision Received

• Supervision: Performs a variety of routine work within established policies and procedures, receiving detailed instructions on new projects and assignments.

About Lonza
At Lonza, quality and compliance are central to our mission of enabling a healthier world. Our teams across the globe collaborate to ensure that every system, process, and product meets the highest standards of excellence. Guided by our values—Collaboration, Accountability, Excellence, Passion, and Integrity—we foster innovation and continuous improvement. By joining Lonza, you will contribute to shaping the medicines of tomorrow while ensuring compliance with today’s most rigorous standards.