QA Expert Job at Lonza
Looking to build a successful career in the pharmaceutical industry? This QA job at Lonza Careers offers an exceptional opportunity for professionals with a background in Biological Science and quality systems. If you are searching for an opportunity for life science graduates to work in global quality engineering and validation projects, this role is your perfect stepping stone toward a high-impact career.
About the Company
Lonza is a global leader in life sciences, dedicated to enabling a healthier world through high-quality products and services. With a strong focus on collaboration, accountability, excellence, passion, and integrity, Lonza ensures that all systems and processes meet the highest regulatory and quality standards while fostering innovation and continuous improvement.
Job Details:
- Job Title: QA Expert – Project Delivery (CQ & CSV)
- Location: Hyderabad, India
- Company: Lonza
- Reference ID: R75325
Role Overview
The QA Expert – Project Delivery (CQ & CSV) is responsible for ensuring compliance in commissioning, qualification, and validation (CQV) activities for equipment and computerized systems within cGMP pharmaceutical manufacturing. This role provides strategic quality oversight, translates regulatory requirements into actionable project deliverables, and represents Global QA in cross-functional initiatives to maintain consistency and compliance across CAPEX projects.
Key Responsibilities
- Ensure qualification and validation activities comply with company quality standards and global regulatory requirements
- Review and approve commissioning, qualification, and validation protocols and reports
- Provide expert guidance on cGMP regulations and global compliance standards (e.g., FDA, Swissmedic)
- Assess the impact of evolving regulatory requirements on project execution
- Represent Global QA in cross-functional teams to ensure alignment with engineering and quality standards
- Support Project Quality Reviews (PQRs) and participate in internal audits across CAPEX projects
- Review technical documentation, risk assessments, and regulatory submissions
- Support inspection readiness and audit processes for ongoing and new projects
- Ensure adherence to data integrity principles and drive improvements in quality processes
- Translate regulatory trends and audit outcomes into continuous improvement initiatives
- Collaborate with global engineering, QA teams, and project stakeholders to standardize CQV practices
- Assist senior team members and contribute to overall project delivery activities
Candidate Profile
The ideal candidate is a quality-focused professional with strong expertise in qualification, validation, and regulatory compliance within a pharmaceutical or life sciences environment. They demonstrate analytical thinking, proactive risk management, and effective stakeholder communication.
Educational Qualification
Bachelor’s or Master’s degree in Engineering (Biologics) or Biological Sciences
Experience
- Proven experience in qualification, validation, and compliance in a regulated pharmaceutical environment
- Strong knowledge of GMP regulations and global quality standards
Key Skills & Competencies
- In-depth understanding of commissioning, qualification, and validation (CQV) processes
- Strong analytical and problem-solving abilities
- Proactive approach to compliance and risk mitigation
- Excellent communication and stakeholder management skills
- Ability to work effectively in cross-functional and global teams
- Business fluency in English
Key Stakeholders
- Global Engineering Leads
- Regional QA Teams
- Project Delivery Team Members
Supervision
The role operates within established policies and procedures, handling routine responsibilities independently while receiving guidance and direction on new assignments and projects.
