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.