Provided on-site SAP Administration, Functional Support and development for the company. Supported all functional areas implemented: MM, PP, QM, FICO, IM, WM, SD, and Security.
Unilife was a medical device developer and manufacturer. Headquartered in York, Pennsylvania, Unilife had manufacturing and warehousing facilities in York and an R&D center in King of Prussia, PA. Their primary products were safety syringes, prefilled syringes, drug reconstitution delivery systems, auto-injectors, wearable injector systems and targeted organ delivery systems.
SAP instance was implemented by consulting firm in 6 months without sufficient blueprinting to the company’s needs or work practices. While engaged, I re-implemented the SAP Materials Management (MM), Quality Management (QM) and Production Planning (PP) modules due to many gaps.
The products needed to have batch management functionality. The consulting firm chose to implement a process-industry (PI) module rather than PP module as it implemented batch management by default. In the MM module, none of the products were setup with a shelf life values. This resulted in the system requiring a quality inspection to unblock material after each material movement.
As a medical device manufacturer, the changes to the SAP solution needed to be validated to FDA standards (CFR 820). Working with the directors of Quality and Supply Chain, we validated the solution after each change, such as new material types, number range changes, batch number scheme changes, etc. (Unilife Medical Solutions, Oct 2011 – Aug 2013)
Unilife filed for Chapter 11 bankruptcy in April 2017 and then amended the filing to liquidation in December 2017.