Preferred Skills:

• Bachelor’s Degree or Higher
• 5+ years of professional experience in the MES product knowledge, Pharmaceutical validation concepts and documentation, Pharmaceutical business process domain knowledge cGMP and GDP standards and GAMP Standards
• Hands-on experience in WERUM MES (PAS-X) application with extensive implementation skills.
• MES product knowledge, Pharmaceutical validation concepts and documentation, Pharmaceutical business process domain knowledge cGMP and GDP standards and GAMP Standards
• Good understanding in communication of MES and SAP/other interfacing automation components. Application knowledge in JBoss server functionality and MES Print functionalities.
• MBR Designing, MES to SAP, MES to Automation interface knowledge
• Create business process flow diagram for pharmaceutical product recipes based on the paper batch record. Gather MES Site specific requirement analysis to develop URS and FRS.
• Logically breakdown the recipes. Mfg. process following standards Procedure Unit procedures Operations phases to configure the recipe in to Werum MES (PAS-X).
• Good written and verbal communication skills to effectively communicate with technical and business users.
• Knowledge in GxP terms as per 21 CFR PART 11, Compliance issues and Documentation. Nice to have a Pharmaceutical domain expertise.
• Experience identifying operational issues and recommending and implementing strategies to resolve problems
• Proficiency in German language

Job Roles/Responsibilities:

• Develop create MBR design elements building blocks and workflows in Werum MES (PAS-X) for repetitive use in MBR creation to expedite the process.
• Gather master data and configure upload in Werum MES (PAS-X) Environment & Integrating Werum PAS X with SAP and other automated systems using standard interface.
• Execution of change requests for support and any enhancements as required.
• Update MES documents such as DS, SOP, IQ Protocols as needed for tickets resolutions or any enhancements as required.
• Configuration of system data work centers scales, barcode scanners and printers.
• Lead the recipe design session with business process SMEs & Design MBR recipe equipment workflow status diagram based on the Business process flow.
• Coordinate and support with respective groups/departments and vendors for implementation or hyper care activities after patch or system upgrades.
• Configuration for the impacted components and interfaces including JBOSS, WXI, Scales, and Printers
• Attend periodic review meetings, cutover migration, hyper care support, any enhancements planning, design and/or implementation meetings as required.
• Good at customer handling and liaising with all stakeholders.

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