Document Management Analyst
hace 3 semanas
**Summary**:Responsible for managing QMS Documents, (SOPs, WPs, WIs, FRMs, etc) issuance, updates, withdrawals & periodic reviews from initiation until completion assuring that the processes adhere to the Novartis QM directives, Global SOPs, Health Authorities requirements.**About the Role**:**Major accountabilities**:- Coordinate the issuance and the update of QMS Documents (including Standard Operating Procedures, Work Instructions, FRMs, etc.), in order to ensure compliance with Novartis standards & Health Authorities requirements.- Review CAPAs Plans in order to identify required changes (Inclusions, deletions, modifications) in QMS Documents.- Perform the role of SOP Manager and Coordinator within Electronic Document Management Systems.- Set and provide input on priorities for owned activities.- Demonstrate customer-oriented service mindset in handling and executing deliverables.- Responsible for data compilation and preparation of dashboard on a regular basis to track and report deliverables.- Regularly communicate with customers and partners to collect feedback on support services.- Responsible for writing and updating SOP’s applicable to owned activities.- Follow-up on the actions determined by audits, self-inspection, Quality Manual, etc. for the Document Management aspects.- Ensure efficient, timely and clear communication to all involved partners (local and global functions) as required for flawless follow-up on activities under scope.- Communicate progress and deviations as appropriate in collaboration with team leader.- Build and maintain high expertise and continuously acquire process knowledge.**Key performance indicators**:- Document Management & Artwork processes KPIs and KQIs.- High customer satisfaction/responsiveness (no customer complaints).- Adherence to project timelines and proactive management of upcoming issues.- Generation / delivery of reports related to the administration QMS Documents.- No issues due to non-observance of cGMP, SOPs and no critical deviations.**Minimum Requirements**:**Work Experience**:- Scholarship: Professional related to Chemical-Biological areas: IF, IQ, IQI, IBT, IB, QFI, QFB, QBP, LF or Project Management with Pharma experience.- Experience/Professional: approximately one year of experience in Pharmaceutical Industry are desirable. Solid experience in data analysis and reporting.**Skills**:- Knowledge: Quality Systems; Continuous Improvement; Good Manufacturing Practices; local/international Health Regulations;- Skills: Strives for simplicity and clarity; Digital technology Savvy; Continuous Learning; Solution oriented behavior; Self organization; Stakeholder Engagement; Organizational Savvy; Effective communication; Breakthrough analysis; Agile Mindset; Agile Teams.**Languages**:- English.DivisionOperationsBusiness UnitInnovative MedicinesLocationMexicoSiteINSURGENTESCompany / Legal EntityMX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V.Functional AreaQualityJob TypeFull timeEmployment TypeRegularShift WorkNo**Accessibility and accommodation**:Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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