Job Title: SAP PPQM Lead
Location – Requires ONSITE in Boston, MA
Job Description / Responsibilities:
1. SAP PP-PI CORE Module :- Must have minimum 12 years of SAP experience preferably in Pharma industry with at least 3 full life cycle implementation projects or Production support experience in Pharma Industry.
2. Should have Strong Expertise in configuration and customization of :-
3. Process order management, execution, Material staging with WM-PP interface, scheduling & confirmation etc. Shop floor printing, batch records printing, Label printing etc, Should have expertise in designing of PI sheets & X steps., Should have Very good hands on experience and understanding in regard to the Business Requirements related to Pharma Industry. Should have expertise in batch management and serialized products related to the Pharma industry.
4. Should be familiar with Intercompany Processes involving STO & Handling Unit Management.
5. Design & trouble shooting of MES Interface & other third party manufacturing Interfaces
6. Approval and archival of Electronic Batch Records
7. Knowledge of User exits , IDocs monitoring & trouble shooting.
8. Experience in global roll outs preferably with International based plants with multiple currencies.
9. Must have experience in Testing & documentation including writing enhancement Functional specification
10. ABAP Debugging knowledge is desirable but not essential.
11. Should be capable of stepping in to a Lead role depending on the size and scope of large client engagements within international work environment. Expected to Work closely with IT/Business handling the requirements.
12. Analyze processes make recommendations for changes to support improvements and translate them into SAP solutions that enable the organization to achieve its goals.
13. Identify and recommend alternative methods and technologies to meet business needs Collaborate with ABAP developers to debug SAP system issues in the Production area and deliver custom development enhancements. Coordination with offshore team to achieve the desired results, Demonstrate strategic planning and leadership capabilities by engaging actively with business partners
14. Expertise in Configuration of QM in procurement, production, Sales & distribution, controlling
15. Excellent Skills in configuring and Customizing Quality Planning (Basic data for Quality Management, Inspection planning), Quality Assurance (Quality inspection, Quality certificates) & Quality Control (Quality notifications, QM information system) in QM module
16. Expertise in Configuration of QM in procurement, production, Sales & distribution, controlling
17. Prior experience in the interfacing of External LIMS with the SAP QM module
18. Prior experience on PM interface in Test Equipment Calibration orders
19. Well versed with the Accelerated SAP Roadmap recommendations and documentation management at successive project stages vis-à-vis Project Preparation, sizing & Business Blueprinting, Functional Development, Final Preparation, Go Live and further functional support – Customizing SAP R/3 Production Information System Repositories as per the company specific reporting needs
20. Exposure in creating cost elements, activity types and linking them to cost centers, as required.
21. Good knowledge in Document Management System (DMS)
22. In depth understanding of Business processes, Business work flow and Process Mappings in SAP Environment with Interaction from Business Module Leads and Key Users
23. Experienced in documenting functional Specifications for Client Specific Reports & Layouts, Configuration changes, Modular and Integration Testing and other aspects of software development lifecycle
24. Experience in preparing and conducting “train the trainer” writing and presentation of training documentation, end user training and post implementation support
25. Strong problem solving, analytical skills and ability to make balanced independent decision, Excellent attention to details and ability to communicate effectively with all levels of the organization
26. Strong knowledge on MS Excel on performing macros to eliminate the manual work when required, Strong team player and Good MS office skills
27. Extensive experience in Batch Management with classification and Batch search strategy
28. Designed, Implemented and Configured Inspection Lot Creation, Results Recording, Defects Recording, Inspection Lot Completion, and Sample Management for Quality Inspections
29. Configured and Implemented Quality Certificates, Recursive inspection and source inspection, Specific configuration-related requirements:
30. Extend the QM view of the material master and populating the default information
31. Perform quality notifications that handles NOE’s, QCR’s, Vendor complaints, Perform ‘skip lot’ testing
32. Support country specific testing for products being exported prior to batch release, Set trend limits in testing specifications, Determine sample size based on lot size using ANSI table
33. Create an inspection lot during the creation of a batch, the change of Lot status, or a manual request
34. Configure the Usage Decision codes to align to the Lot status. Re-align the Lot Status values to the SAP stock types
35. The lot status will be automatically updated when the Inspection Lot Usage decision is set
36. Customize the stock positioning function to only move stock from the current lot status to the new lot status, Re-configure SAP QM to activate the use of the ‘Restricted Stock' batch status toggle switch, Set lot as unavailable stock when lot is assigned to an Inspection Lot
37. Work with the Merck S-P Security person to test user authorizations in SAP QM, Develop a process to manage stock movements for the Memphis plant when a usage decision is set
38. The direction of the stock movements may have to change to originate in SAP and sent to DLx, Trigger a requirement (notification) to inspect a lot as a result of any of the following types of activity:
39. Purchase Order Receipts, Production Order receipts, In Process Production Order receipts, Other Goods Receipts, Recurring Inspections, Analytical, Stability, and Micro testing, Lot to Lot transfer, Expiration Date Monitoring, Near Expiration Date Monitoring
40. Related to Global Laboratory Information Management System (LIMS):, Determine if the Inspection Lot needs to interface to G-LIMS-(Lot Origins)
41. Configure SAP QM to enable automatic stock postings when a Usage Decision is entered ,either from G-LIMS or manually
42. Develop functional / technical specifications for a Material Master interface process to G –LIMS. Note: G-LIMS Team to provide an automated interface for the Material master and Vendor master
43. Interface SAP with G-LIMS:, Send inspection details from SAP to G-LIMS, Receive usage decision from G-LIMS to, APIntegration Knowledge with SAP ARIBA CSC, SAP GBT knowledge and expertise, Quality Notification Configurations, Design Custom Workflow for QN, Configuration of New QN types
44. Configuration of Partners and Partner Profiles, Configuration of Code group and Codes
45. Define the scope and document the test scripts for Unit Testing and Acceptance testing, Prepare the data for testing activities
46. Define the scope of cutover activities and perform the same, Help in updating the training documents, SOPs and other documentations, Prepare the business for Go Live
47. Provide the knowledge transfer for Support team and help in transition, Work with Cross functional teams like technical (ABAP), Interface teams, BASIS and security teams
48. Provide post Go Live hyper care support, Attend regular status meetings with the project team, Communicate daily/weekly about the status of the project items, Help update the Project metrics
49. 12+ Years of SAP MM experience in implementation and Support.