SUMMARY

• Has a proven global, national, and local SAP implementation experience with in - depth knowledge of a business process oriented approach, transforming business/industry requirements into practical solutions with quality, accuracy, and speed
• Managed and implemented all SAP R/3 releases from 3.1 h through 4.7, ECC/ERP 6.0 and EWM 7.1 & 9.2
• Has proven cross-functional skills in establishing best business practices & industry standards, issue resolutions & coordination, change management, and project performance metrics
• Incorporated comprehensive, concept-to-completion approach including ASAP methodology and business process re-engineering, for large scale and medium sized implementations, and systems integration projects
• Delivered SAP Industrial Solutions like IS-Pharma, IS-Utilities & Hi-tech
• Managed several full-cycle SAP implementations with ASAP methodology and Rapid deployment and JIRA development methodologies for food processing, and utility industries.
• Managed and implemented SAP QM (Quality Management) for major global pharmaceuticals, medical device manufacturers, plastics and chemical and aerospace & defense industries in the US in accordance with FDA/cGMP/USDA regulations/compliance requirements.
• Has an excellent working knowledge of other SAP modules like FI/CO, SD, HR, and bolt-on like MES - including all integration aspects within SAP and with other legacy systems.
• Has an excellent working knowledge of ABAP objects, enhancements/user exits, data migration tools, interfaces, and system landscape.
• Has excellent oral and written communication skills, including proficiency in writing functional specifications, development documents, SOPs, training materials & presentations, and test scripts
• Has proven inter-personal skills, effective teamwork, self-motivation, adaptability, analytical thinking, result-orientation, and professional approach
• Managed and Supervised Engineering, Sales & Distribution team, Performed Project Management activities for discrete manufacturing operations in U.S.

PROFESSIONAL EXPERIENCE

SAP QM Team Lead

Confidential

Responsibilities:

• Assisted in blue printing of the future state processes such as incoming, in-process, final inspections and certificate generation
• Delivered functional specifications to interface incoming inspections to LIMS (Predisys) prior to final release
• Written functional specification documents to implement Workflow processes to support CAPA / 8D Processes
• Provided POC over FMEA tools and components such as control plans (CP) in SAP with a focus on product design-related deficiencies to improve the mold design
• Explained the end to end functionalities of SAP Audit Management and associated components for potential Vendor audits
• Trained SMEs on various components of Quality Management and to leverage the current business processes
• Completed Integration tests and assisted with UAT test cycles and supported go-live operations of North American sites

Lead. Consultant

Confidential

Responsibilities:

• Participated and assisted the project team in analyzing the global business processes across U.S, Europe and Asian operations for fit-gap analysis against a vanilla ECC 6.0
• Provided Workshops to core team members / global SMEs on Quality Management and management of business processes using SAP Serialization
• Assisted in designing the process flows with integration points between Sales (OTC), In-bound deliveries and product nonconformance (RMA) and subsequent controls
• Defined the process flows for Quality inspections (In-bound, In-process & Configure to Order) and hand-shakes between ECC 6.0 and Manufacturing Execution systems (ME/MII)

Lead. Consultant

Confidential

Responsibilities:

• Assisted the project team in analyzing the global business processes across North & South America, Europe and Asian operations in conjunction with current state of activities to future to-be state of business operations
• Designed, configured, developed and implemented template based structure on global scale for markets such as US, Puerto Rico, Mexico & Bermuda
• Written blue print documentation based on final approved GAP list for Europe Market requirements and regulations (European Commission)
• Assisted project team in training / educating European market team with SAP functionality and its correlation with current business processes
• Written functional specifications and developed solutions for special quality sample calculations and subsequent product dispositions (US exports) based on European Commission guidelines
• Provided guidance and recommendations based on GMP and business best practices to comply FDA 21 CFR Part - 11guidelines
• Configured the plant specific settings to enable SPC processing and control charts during production processes
• Written functional specifications to meet CAPA and other business requirements and worked with technical resources such as ABAP and Workflow to perform various levels of testing
• Developed functional / technical solution for External Manufacturing Quality Assurance (EMQA) activities
• Designed and configured quality notification objects to meet Plant maintenance (PM) needs
• Worked and developed functional specifications on QM-MM integration aspects to identify latest material revisions upon GR and Manufacturer part number setup (AMPL)
• Worked and developed functional specifications on QM-WM integration aspects to identify appropriate bin locations for sample sizes and as well as identifying number of containers for sample management
• Developed functional specifications on QM-PP/PI integration for in-process inspections and direct data transfer from PI sheets to batch master characteristics
• Developed functional specifications on QM-SD / Outbound deliveries to customize outgoing Quality Certificates incorporating Multiple specifications
• Developed functional specifications for SQL LIMS in / out-bound activities via TIBCO middleware
• Written integration test cases based on the requirements and assisted Mexico Super Users during their OQ / PQ testing cycles
• Assisted project team and business leads on design of Security profiles, roles and auth. Objects for proper transactional and master data activities at plant level across global scale

Lead. Consultant

Confidential

Responsibilities:

• Provided recommendations, designed and implemented solutions to control the stocks between manufacturing and Tier 1 / Tier 2 distribution centers globally
• Configured necessary QM-WM interface activities to handle QA sample stocks
• Configured the system to enable serial number assignment and subsequent stock dispositions
• Recommended and implemented the approaches to safeguard the containment of pre-inspected finished goods Between manufacturing and Tier-1 Distribution Centers globally
• Written functional specifications to link usage decision of inspection lots created at manufacturing and Distribution Centers considering batch splits
• Written specifications to prevent usage decision by users who are part of results recording tables
• Implemented user exits where necessary by minimizing the SAP program core modifications
• Written functional specifications for LSMW and Inspection plan upload programs for data conversions