Senior QA Specialist QA Documentation

India, Hyderabad

Location: Hyderabad

Be part of Lonza’s world-class Quality Systems & Compliance team in Visp. As a QA Document Specialist , you will be responsible for the compliant management, oversight, and archival of GMP-relevant documentation. You will serve as a key decision-maker regarding the lifecycle of quality records and retain samples, ensuring full alignment with regulatory expectations and customer requirements while acting as the primary QA representative for all archiving activities.

What you will get

• An agile career and dynamic working culture.
• An inclusive and ethical workplace.
• Compensation programs that recognize high performance.
• Opportunity to lead critical compliance processes like True Copy Scanning.
• Professional growth within a globally connected Quality network.
• The full list of our global benefits can also be found on https://www.lonza.com/careers/benefits .
  
  

What you will doDocument Management & QA Oversight

• Ensure compliant management of Quality-relevant documents from finalization until dispatch to customers or destruction, in strict alignment with internal SOPs.
• Provide QA oversight to guarantee documentation integrity, traceability, and unwavering adherence to GMP archiving requirements.
• Drive critical decisions regarding the appropriate disposition of archived paper documents (e.g., customer delivery vs. destruction) in close collaboration with QA Operations and document owners.
  
  

True Copy Scanning Process

• Own, optimize, and maintain the True Copy Scanning process, including the creation, revision, and periodic review of all related SOPs.
• Ensure process compliance and efficiency by aligning the True Copy workflow with regulatory and internal requirements.
• Provide specialized training to all employees involved in scanning and documentation workflows across the site.
• Maintain system access rights and ensure proper segregation of duties within documentation tools.
  
  

Archiving & Samples Disposition

• Act as the primary QA representative and main contact person for external archiving services, ensuring third-party compliance with Lonza standards.
• Direct the handling of GMP documentation exceeding defined retention periods, determining if destruction or customer dispatch is required.
• Manage the evaluation process for retain samples exceeding retention dates, collaborating with QA Operations and project owners to reach compliant outcomes.
  
  

What we are looking for

• Experience in Quality Assurance or Documentation Management within a highly regulated GxP/GMP environment.
• Deep understanding of Data Integrity and archiving regulations (e.g., Annex 11, 21 CFR Part 11).
• Strong decision-making skills with the ability to evaluate risks regarding document retention and destruction.
• Excellent communication and coordination skills to liaise effectively between QA Operations, document owners, and external partners.
• High attention to detail and organizational skills to manage complex documentation lifecycles and retention schedules.
• Fluency in German and English (written and spoken) is required for this site-critical role.
  
  

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: R75352

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