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Job Details


Novartis

Engineering Documentation Specialist

Pharmaceuticals

All

No

Hicksville, New York, United States

Job Description

This role will support associates in Information Governance Management (IGM) and Business Information Management for the site. The incumbent will be responsible for site oversight of non-IT IGM and Business Information Management while supporting GxP activities in the Engineering department. Will also administer Quality Systems/ Processes including documentation and monitoring of actions.

Takes a key role in the execution of the following activities within the local organization:

• Implementation of Information Governance Management (IGM) and Business Information Management procedures
• IGM Manager in RC meetings Tracking of non-IT actions in the gap registers

Policies, Directives, Guidelines (“Regulations”)

• Distribute IGM and Business Information Management regulations to the local IGM Organization
• Collect and provide usability feedback of regulations
• Report any weaknesses in IGM and Business

Information Management regulations to the IGM Manager
Training and awareness:

• Perform training for the IGM Coordinators and identify any additional training requirements based upon IGM coordinator feedback
• Report on training completion at the site level for all IGM awareness campaigns and for routine IM policy training
• Report to the IGM Manager any training gaps with remediation plans
• Distribute training and awareness material to IGM Coordinators
• Attend IGM trainings upon request of the IGM Manager

Provide Support:

• Provide day-to-day support for Local IGM organization in IGM and Business Information Management
• Collaborate with IGM Manager to identify site response to weaknesses identified in Business Information Management
• Creation of security incidents based upon feedback from IGM Coordinators
• Escalate recurring security incidents to the IGM Manager
• Ensure completion of annual physical archive “clean-up” day

Information risk management process:

• Ensure that the IGM Records Inventory is maintained through the local IGM organization
• Support remediation actions and record the actions in the IRM Tool with IGM manager
• Routinely report on the status of non-IT gap actions to the Business Units

Generally support the lifecycle for information regarding:

• confidentiality
• integrity
• availability
• retention

IGM BIM Coordinators:

• Lead the BIM coordinators meeting
• Prepare the agenda for BIM coordinators meeting
• Distribute BIM meeting minutes
• Meet with IGM manager to address BIM initiatives/progress

Additional specific tasks:

• Actively cooperate and share experiences with other IGM Lead Coordinators from the other sites in the region
• Continuously report on issues, risks, exceptions, etc.
• Point of contact of the site document archival and work with offsite archival (e.g. Iron Mountain)
• Ensures the integrity of all Quality Systems records and data, as applicable and collaboration of own team with other functions and departments
• Ensures an adequate level of education, GxP knowledge
• Updates & maintains relevant information in electronic systems (e.g. Change Control, Documentation, Training)
• Follow up and monitoring of Engineering actions (e.g. CAPAs, actions, metrics, Quality plan)