QA Operations Lead

职位描述
-Responsible for managing quality aspects within area of responsibility and to ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements and the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures

主要职责
Major Accountabilities:Functional Breadth, Critical Negotiations, People Leadership, Operations Management and Execution, Collaborating across boundaries, Project Management  Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receiptDistribution of marketing samples (where applicable)Key Performance Indicators:On-time & GMP-compliant release of dosage formsNo Complaints about inspections by authorities in your own area of responsibility without these being noticed & communicated beforehand.Successfully Support continuous improvement ProjectsExecutes batch release in compliance with registrationAs per local regulatory requirement and global guidance/SOP to set up local documentation hierarchyQuality system management (e.g., Change Control, Deviation, Audit &Inspection, CAPA, QE, CONDO, etc.)Validation Batch Record review; Validation protocols review; Deviation management; On site Quality monitoringSupport and oversight validation activitiesAudit and Inspection preparation and readinessFunction representative to be involved in global and/or local project if any.Collaboration in GxP audits/inspectionsOversight of Quality OperationsMaster Batch Record review and approvalAs site QP or delegation to release productQA for Quality Control & AS&TQA Operational ExcellenceWork Experience:Good Manufacturing Practices (cGMP)Audit & Inspection ManagementRelease ManagementQuality AssuranceQuality ComplianceQuality Management SystemsTechnological ExpertiseSkills:CollaborationContinuous Improvement mindsetDealing With AmbiguityRegulatory requirements knowledgeProblem Solving SkillsLeadershipCommunication skillsData IntegrityDigital savvinessLanguages:English.