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.