Validation Specialist (Data Integrity)
Today Lonza is a global leader in life sciences. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
The Data Integrity Specialist is a Subject Matter Experts (SME) for data integrity requirements and expectations. The DIS is responsible for management and oversight of data integrity issues in clinical and commercial GMP operations, including identification and investigation of suspect data integrity events managed thru the existing QMS processes. The DIO serves as a key member of the GMP Data Governance Program to ensure that data integrity regulations and expectations are effectively incorporated into site GMP Operations and decisions. The individual will be responsible to oversee execution of the Strategic Data Integrity Plan and relevant annual Plans, in partnership with IT, QC, QA and other stakeholders including Lonza Corporate and key customers as appropriate.
- Monitor worldwide regulatory requirements and expectations for data integrity
- Inform senior management of potential areas of risk
- Develop the Data Integrity Plan including prioritized activities, responsibilities and timelines for activity completion.
- Performs audit trail´s data integrity risk assessments as per current policies.
- Periodic review of validated systems/equipment: Data Integrity, Audit Trail, Authorizations and Permissions, Backup copies etc.
- Review the effectiveness of the data governance systems to ensure data integrity and traceability Identify improvement activities
- Review and approve the qualification/validation protocols
- Ensure the compliance of the local qualification/validation activities with Lonza Corporate and regulatory requirements.
- Maintain inventory of all policies and procedures that support data integrity.
- Follow up of corrective actions and establish timelines for resolution and responsibilities (CAPAs).
- Lead gap assessment effort for new and existing regulations and guidance, identify gaps requiring remediation and propose plan
- Develop and implement continuous improvement actions looking for a more efficient and modern qualification/validation.
- Maintain strong working relationships with key stakeholders.
- Manufacturing, Quality or Validation – Advanced Experience
- Bachelor Degree. Preferred area of study in Computer Sciences, Microbiology, Biochemistry, Chemistry or Related Science Fields.
- Working experience within a regulated cGMP industry
- Experience in equipment qualification.
- Intermediate experience working in Quality Control Laboratory or enterprise computer systems and GMP Quality Systems such as TrackWise, LIMS, iLAB, MODA, and Empower
- Working experience in Analytical Laboratory testing (ie: protein purification and characterization, protein chromatography, SDS-PAGE, Western blotting, and amino acid analysis, TOC, Bioburden, Endotoxin, Elisa, Flow cytometry, Microbiology) preferred
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.