GMP and Data Integrity Officer
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
The Quality Operations GMP and Data Integrity Officer is responsible for first level, hands on, day-to-day cGMP facilitator role for all site related GMP activities.
Your responsibilities include, but are not limited to:
This position will be expected to work a 5 days/8 hour work shift. Weekend support and some evenings are required.
• Provides oversight to operations on the production and QC shop floor, supporting operators and support staff as needed to identify and address product quality and compliance issues as they arise.
• Review and audit production batch records, and/or QC related documentation, to ensure adherence to Novartis policies, SOPs, and cGMP requirements.
• Oversight of aseptic operations including but not limited to ViMOS, APV program, EM program, walkthrough program, etc.
• Triaging of issues, initiate deviation reports into the system and partner with PU, and other areas for issue resolution.
• Actively participate in process improvement initiatives aiming for Right First Time (RFT) on documentation and deviation reduction in collaboration with Process Expert teams.
• Present systems and provide documentation for self-inspections and external audits.
• Interact with FDA, partner, and supplier auditors/inspectors, as needed.
• Drive, monitor and assure delivery of the AAA DI Plan, including DI communication and engagement plan, and periodically report status / progress to AAA leadership through the AAA SQRB, TechOPS Business review and Novartis Group Quality as required. Support Escalation
• Continuously improve data integrity knowledge base and understanding: Identify training needs, and ensure availability of appropriate and functionally relevant training materials; where training does not exist, facilitate creation of material and delivery of training.
• Drive sustainable improvement in detecting and mitigating DI risk by working with SMEs to embed DI focus in existing site programs, for example, self-inspection program, continuous improvement program, Gemba walks, VIMOS, etc.
[Register to View]