Job Description :
Job Description :
Functional knowledge of Trackwise and experience of migrating data and knowledge of data model.
· Provide support to the R & D Quality Assurance Compliance QAC
· Minimum 2-4 years of Quality Assurance/Quality Engineering/Engineering/Operations experience – Minimum 6-8 years of Track wise configuration and data model design, Development, Security and reporting.
· Experience in configuring investigations and CAPA activities. Experience in quality improvement processes, quality systems and tools. Knowledge of regulatory agency requirements.

· Main Areas of Responsibility

· Trackwise configuration of processes for Non-conformances: Review non-conformances and, if required, initiate Quality Investigations. Partner with authors or others to ensure records are factually written and accurately portray the event. Verify that the event is properly trended, evaluated, and assessed to ensure appropriate actions are taken.
· Trackwise configuration of processes for Corrective and/or Preventive Actions (CAPA): Ensure that corrective actions are configured appropriately for the elimination of root cause and prevent reoccurrence. Proactively work/motivate and guide facility teams to ensure corrective action efforts address root cause and results are effective. Ensure that all actions are verified and/or validated and do not adversely impact finished devices.
· Effectiveness Checks (EC): Assist in the development of effectiveness check plans and ensure that all effectiveness checks are appropriate at assessing the effectiveness of closed CAPAs. Confirm that effectiveness checks utilize statistically-sound sampling plans and results are adequately assessed to determine pass/fail status.
· Electronic CAPA system (TrackWise®): Provide development, security, field level authorizations, role based and person based security configuration and setup, guidance/training to all personnel performing activities within the electronic CAPA system (TrackWise®
· NCR/CAPA System Metrics: Assist in the NCR/CAPA system data collection, interpretation and documentation to support all system metrics (monthly, quarterly, and ad hoc report needs) on a timely basis.


Technical Requirements

Demonstrated Solution Architecting skills at for End to End solutions.
Demonstrated Domain expertise in understanding business processes of Life sciences Industry.
Demonstrated skill in gathering business requirements in order to manage cross-functional processes.
Strong Data Modeling skills to include data quality, source systems analysis, business rules validation, source target, mapping design, performance tuning and high volume data loads.
Demonstrated project management skills, specifically on technical projects.
Demonstrated ability to prioritize and plan work activities, use time efficiently and develop realistic action plans.
Knowledgeable in designing and outlining business processes, sub-processes and their links to automated tasks in IT.
Ability to adapt to rapidly changing technology and apply it to business needs.
Demonstrated strong analytical and conceptual skills and the ability to create original concepts on projects.
Demonstrated ability to isolate, diagnose, troubleshoot and resolve data, system issues and performance issues.
Demonstrated ability to determine resources needed to meet objectives and coordinate work efforts to meet objectives timely.
Demonstrated customer service skills including understanding users'' needs, offering solutions and following up to ensure end user success.
Demonstrated ability to work independently, with limited supervision and the ability to make decisions with minimal direction, as well as in a team setting to establish and maintain effective working relationships with employees and managers in a team-based and union environment.
Effective organizational and interpersonal skills including both written and verbal communication skills with all levels of associates in the organization, with the vendor community, and the public. This includes the ability to communicate with both technical and non-technical individuals.
Ability to influence and collaborate with individuals of diverse backgrounds and at all levels within the college.
Demonstrated ability to maintain confidentiality.
Knowledge of and experience working in the field of Higher Education.
System Design, development and testing. ( must have)
Documentation skills

Technical Skills - Trackwise, Erwin Data Model Tool, Multiple ETL tools. Multiple BI Tools.
             

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