**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, Integral 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.
Division
Operations
Business Unit
Innovative Medicines
Location
Mexico
Site
INSURGENTES
Company / Legal Entity
MX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V.
Functional Area
Quality
Job Type
Full time
Employment Type
Regular
Shift Work
No
**Accessibility and accommodation**:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

📌 Document Management Analyst (Baja California Sur)
🏢 Novartis
📍 Baja California Sur