India, Hyderabad

Digital Quality, CSV Systems Specialist

Location: Hyderabad

Be part of Lonza's world-class Quality and Regulatory team. As an E-Validation System Expert, you will be the primary business administrator for the Kneat Gx platform, driving the digital transformation of our validation processes. You will play a crucial role in ensuring the integrity of our computerized systems through standardized documentation and electronic records, helping Lonza maintain the highest levels of compliance in bringing life-changing therapies to market.

What you will get

An agile career and dynamic working culture.
An inclusive and ethical workplace.
Compensation programs that recognize high performance.
Global exposure and the opportunity to work collaboratively across global quality workstreams.
Comprehensive benefits package including medical insurance and wellness programs.

What you will do

System Administration: Serve as the Acting Business Administrator for Kneat Gx (CSV workspace); manage user access, role configurations, and permission requests while acting as a deputy for C&Q Workspaces.
Training & Support: Deliver and maintain comprehensive Kneat training for IT projects and operational validation activities, providing ongoing technical support to end-users.
Lifecycle Management: Assist with system upgrades, periodic reviews, new template rollouts, and business process adjustments to ensure the e-validation platform remains state-of-the-art.
Documentation Strategy: Support the implementation of efficient CSV documentation for IT projects and global procedures; create protocols, scripts, and reports for infrastructure and application projects.
Standardization: Drive the optimization of e-validation records and processes, ensuring alignment between platforms, sites, and project teams through harmonized templates and test scripts.
Project Support: Execute IT projects and change requests by driving documentation within various electronic platforms, including TrackWise, Kneat, and DMS.
Audit & Inspection Readiness: Support internal audits and regulatory inspections by providing summarized data, oversight of key topics, and the creation of storyboards and reports.
Compliance Reporting: Assist senior team members with monthly updates, quarterly inspection reports, and regulatory CAPA reports to ensure global standards are enforced.
Data Integrity: Uphold data integrity principles in accordance with Lonza policies, proactively identifying and improving processes to ensure compliant electronic records.

What we are looking for

Experience: Significant experience in Computer Systems Validation (CSV) with a strong focus on electronic validation platforms; experience in system administration is highly preferred.
Technical Expertise: Advanced proficiency in Kneat Gx or similar e-validation software; familiarity with TrackWise and Document Management Systems (DMS) is a plus.
Education: Degree in Life Sciences, IT, Engineering, or a related field.
Compliance Knowledge: Solid understanding of GxP regulations, GAMP 5, and 21 CFR Part 11 requirements regarding electronic records and signatures.
Soft Skills: Strong analytical skills with a focus on process optimization and the ability to train diverse groups of users.
Communication: Excellent English communication skills, capable of translating complex system requirements into clear business processes.
Mindset: A detail-oriented self-starter who values standardization and is committed to continuous improvement in a digital quality environment.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of 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, and that's the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you're ready to help turn our customers breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to shape the future of life sciences Apply now.

Reference: R75675

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