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Sap Qm/batch Management Expert Resume

SUMMARY

  • 14+ years of experience in SAP.
  • SAP QM Functional consultant with experience of implementation, configuration and integration with SAP MM, SAP PP and exclusively on QM module
  • Three full life cycle implementations for SAP QM in integration with MM and PP with knowledge of version upgrade and experience in the following SAP R/3 versions 4.6c, 4.7 and ECC 6.0
  • Worked on projects to implement SAP QM under ASAP methodology on all stages of project - Requirement Gathering and Analysis, Project preparation, Business Blueprint Mapping, Gap analysis to customization, Realization, Final preparation, Go-live and post Go-live support
  • Rich experience in Life sciences domain and Pharmaceutical industry with deep understanding of the need of Quality Assurance and Quality Control processes.
  • Deep understanding of GxP, GDP and GMP requirements of Pharma industry.
  • Worked on scenarios like Make-To-Order, Batch Management, and Batch Where Used List etc.
  • Experience in integration of SAP QM with other quality/compliance systems like Trackwise, LIMS etc.
  • Deep understanding of Batch Management integration with Supply Chain processes.
  • Experience in working with multiple vendors and geographically distributed teams
  • Experience in leading teams and working as end-to-end solution design architect.

PROFESSIONAL EXPERIENCE

Confidential

SAP QM/Batch Management expert

Responsibilities:

  • Conducting blue-print workshops, implementation team trainings and creation and review of standard papers, concept papers, user training manuals, review of Roles and Authorization concepts
  • Worked on implementing new QM process for supplier evaluation, quality notification, deviation management, batch release process to support quality approval of products before they can be shipped to marked
  • Built their Batch Management setup for the manufacturing sites in order to support the supply chain processes
  • Created batch determination, batch approval and batch derivation rules.
  • Enhancement on Usage decision transactions for batch approval
  • Integration with Trackwise system to support the quality notification and deviation management process
  • Integration with External LIMS system to integrate Inspection lot processing with Manufacturing and batch approval process.
  • Provide feedback and review of end user training documents
  • Work on solution manager for documentation and configuration update
  • Review job roles along with role to position mapping to build user access
  • Working as one of the lead solution design expert in order to provide end to end solution with integration of procurement, manufacturing, quality and supply chain processes
  • Coordinated with multiple vendors from geographically distributed teams for a successful development, testing and deployment of a single project

Confidential

SAP QM business analyst

Responsibilities:

  • Work with business super users to generate/gather requirements
  • Prepare high level solution designs and effort estimates
  • Prepare Functional and test specifications as per ASAP methodology
  • Perform and document Unit tests and Integration Tests as per Pharma Quality processes and GxP standards
  • Fully responsible for their custom solution of building databased of 3rdParty vendors which provides oversight of outsourced activities
  • Enhancements in Certificate of Analysis and Certificate of conformity
  • Enhancements in the custom solution built for stability studies
  • Configuration of new document types in SAP Document management systems
  • Enhancements in batch release process via usage decision
  • Responsible for supporting the master data and transactional data interface with TrackWise
  • Responsible for resourcing, mentoring and time tracking activities for the team
  • Coordinated with multiple vendors from geographically distributed teams for a successful development, testing and deployment of a single project

Confidential companies based out of Switzerland

SAP QM business analyst

Responsibilities:

  • Resolving high priority and complex tickets
  • Managing a team of SAP PP/QM consultants for Incident Management.
  • Timely analysis and resolution of the day-to-day SAP application issues including incident management, service request and problem management.
  • Interact with users of Manufacturing and QA/QC area to elicit various requirements like performance, scalability, reliability, availability, maintainability.
  • Coordinating among the multiple stakeholders including business users, technical teams and, application manager for successful and time resolution of tickets.
  • Carrying out RCA (Root Cause Analysis) and CAPA (Corrective and Preventive Actions) for the critical incidents and problems.
  • KPI (Key Performance Indicators) reporting for the application support and maintenance statistics.

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