Description de l'offre
This position will be expected to work a 4 day/10 hr work shift. (Sunday through Wednesday or Wednesday through Saturday, some evenings may be required) • Provides oversight to operations on the 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 to ensure adherence to Novartis policies, SOPs, and cGMP requirements. • Interface closely with the QA Batch Release Managers and Specialists/PU to assist with batch record release and compliance issues. • Initiate deviation reports in Trackwise and partner with the QA Batch Release Managers and Specialists/PU for issue resolution. • Actively participate in process improvement initiatives aiming for Right First Time (RFT) on documentation. • Ensures adequate levels of documentation are adequate and compliant to existing procedures • Participates in activities associated with event resolution and CAPAs with a focus on organizing and attending cross-functional meetings • Implements and ensures adherence of appropriate regulations and Novartis quality standards. • Write, review and approve Standard Operating Procedures (SOPs), as needed • Present systems and provide documentation for self-inspections and external audits. • Interact with FDA, partner and supplier auditors/inspectors as needed. • Champion a Quality Culture and ensure a safe working environment. • Represent QA at corporate and site operational and cross-functional meetings, providing QA input and disseminating information back to QA as needed. • Complete job-related training as required
QA Floor Specialist, Operations
BS/BA in Biological Sciences or equivalent relevant career experience may be accepted. Fluent in speaking and writing English. • 3 + years of experience in a Pharmaceuticals environment. • Knowledge and understanding of cGMPs, keeping up to date with current industryissues and changing regulations.
Novartis Technical Operations
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.