Role Description
Recipe Author Description Design, configuration, and rollout of ROCKWELL FTPS for pharmaceutical clients. Prepare and review Recipes and workflows such as cleaning worksheets and calibration records. Conduct mock MBR executions, validate design logic, and ensure readiness for production. Review executed eBRs and provide technical support for validation and troubleshooting. Drive digitalization initiatives, converting manual process documents into PAS-X MES workflows. Deliver operator training sessions on ROCKWELL FTPS functionality and ensure GxP compliance. Collaborate with QA, IT, and production teams to standardize MES operations. End-to-end MBR (Master Batch Record) verification activities within ROCKWELL FTPS, ensuring accuracy, completeness, and regulatory compliance. Review and approve electronic MBR designs against approved paper batch records, process flow diagrams, and control strategies. Define and executed MBR verification strategies, including challenge testing, boundary condition checks, and exception handling.
Ensure MBR alignment with global MES templates, site-specific requirements, and standard design principles. Cordiant cross-functional reviews with MBR designers, MES SMEs, QA, manufacturing, and validation teams. Identify and resolve MBR defects, data integrity gaps, and workflow inconsistencies prior to validation and release. Author and maintain MBR verification protocols, checklists, and summary reports. Support UAT, OQ, and PQ phases by providing verified and compliant MBR content. Mentore junior reviewers and established best practices for MBR lifecycle management. Ensure readiness for regulatory inspections and audits through robust documentation and traceability. Skill
Design and configure MES recipes using Rockwell PharmaSuite or comparable systems.
Translate process requirements into scalable, validated electronic batch records.
Partner with manufacturing, quality, and engineering teams to enhance efficiency and compl
📌 Lead I (Bengaluru)
🏢 UST
📍 Bengaluru