Job Description

Gathering requirements for PI designing of a product Liaising with various product (operations, validation) experts and subject matter experts to determine the requirements for the new PI\'s desgning. Designing and developing the master data for equipment management, Inventory management, User management in MES Design and creation of MBR for specifications on Bill of parameters (BOP). Design and creation of complex PI\'s for Weighing & Dispensing, Manufacturing and Packaging processes. Site specific requirement analysis for each of the above processes and convert them into Batch Records Validation of the created PI\'s for site deployment Providing status updates to the Project Manager on a day-to-day basis on progress, issues, and risks. Work with product vendor on product related issues during upgrade Troubleshoot and defects resolution during validation of PI\'s. Strong Pharmaceutical, Bio Tech, Manufacturing and Shop Floor Order processes knowledge to convert the site requirements into Batch Records End to end implementation experience of Siemens Opcenter EXPH. Experience on Siemens Opcenter EXPH modules like User management, PI Management, PI Process, PI Review, Weighing & dispensing, XSI console, Equipment Management, Material Flow management, Weigh & Dispense. Experience on SAP-MES interface, L2 integrations, report development, Knowledge of ISA95/S88 standards & practical use of these standards in application design, Knowledge of Pharma manufacturing. Good Communication and Analytical skills Hands on Experience in Siemens Opcenter EXPH Specification, Execution, Compliance & Performance Module. Experience in Siemens Opcenter EXPH- Configuration, Customization Experience on Siemens Opcenter EXPH Installation, Upgrade, Development and Configuration. Knowledge of GxP, GAMP, 21 CFR Part 11

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