Associate Analyst - Quality Operations

Associate Analyst - Quality Operations

Job Description Summary

-Supports all GxP activities in the Quality department.
-Administers Quality Systems/ Processes including documentation, metrics and monitoring of actions.
-Supports establishment of Quality operational processes.
-Performs routine GxP Compliance/ Operational activities according to Novartis Quality Standards. Supports Quality Projects and initiatives.

Job Description

•        Adhere to internal operational requirements such as KPI (Key Performance Indicators) reporting, managing tickets, and following other internal processes and procedures

•        Engage in any special tasks or activities needed to fulfil business requirements

•        Accuracy in using computer systems, software, and applications related to quality management such as SAP, MS Office, etc.

•        Produce and interpret predefined and customized reports in various systems GxP compliant electronic systems (like AGILE PLM, AQWA etc.) and carry out necessary follow-up actions.

•        Regularly interact with partners, soliciting feedback on common objectives and deliverables

•        Learn and enhance understanding to create data-driven insights

•        Comply to the applicable Novartis operating procedures as per legal/ IT/ P&O requirements

•        Understanding of QMS including documentation, regulatory requirements, audits, and process improvement.

•        Awareness of regulatory affairs and guidelines related to the pharmaceutical industry such as FDA regulations, GMP, GLP, and ICH guidelines.

•        Oversee quality compliance, including APQR plans, SharePoint updates, QAA (Quality Assurance Agreement), audit CAPA management, documentation handling, and supplier record management.

•        Create and review GxP documents including SOPs, working procedures, trend reports, qualification reports and technical investigations, as and when needed

•        Provide active support during internal and external audits

•        Identify areas for process improvement, find solutions, and address quality-related problems efficiently.

•        Compliantly manage the in-scope training matrix.

•        Define system setup and coordinate learning management system maintenance with administrators.

•        Handle all in-scope reporting requirements.

•        Communicate the availability of learning content to support NTO associates' curiosity and growth.

•        Manage local learning events for NTO Operations Hubs and support events at in-scope sites.

•        Apply solid instructional design methodology, incorporating adult learning theory, interactive activities, and competency-based evaluations.

•        Create engaging learning activities and compelling course content to enhance retention and transfer.

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Skills Desired

Collaboration, Communication Skills, Data Integrity, Deadline Adherence, Dealing With Ambiguity, Digital saviness, Health & Safety Regulations Knowledge, Leadership, monitoring, Problem Solving Skills, Punctuality, Regulatory Requirements knowledge

Experience Level

Mid Level