769 million. That's how many lives are touched by Novartis products globally. And, while we're proud of that fact, in this world of digital and technological transformation, we must ask ourselves this: how can we continue to improve and extend even more people's lives?
Senior QA Validation Specialist is responsible for quality assurance oversight of Qualification, Validation, in relation to Facility Equipment, Computerized Systems, Laboratory systems in order to meet Novartis, AAA and regulatory requirements.
Your responsibilities include, but are not limited to:
* Author, review and approve validation and qualification procedures, plans, protocols and reports. Train and guide site personnel in validation area. * Review and approve changes, deviations and procedures related to facility, computerized systems, laboratory or products. Ensure proper assessment with respect to Qualification and Validation is conducted. Perform QA oversight for Validation and Qualifications activities for Manufacturing and QC studies. * Perform qualification and validation coaching and training for the quality team and other associates within Production and QC. * Ensure timely escalation of risks in meeting timelines are communicated. * Support commercial product FDA/Regulatory interactions for the Indianapolis site activities and products to ensure successful regulatory submissions and audits. Provide guidance on audit preparations or leading investigations whenever required. * Provide support to peers within the QA Operations team. * Support QA Operations as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance and data integrity.