PharmaSuite EBR Specialist | GMP, Validation & Go

Required Skills

• Strong understanding of pharmaceutical manufacturing processes, especially solid oral dose and packaging
• Expertise in Good Documentation Practices (GDP) and Good Testing Practices (GTP)
• Ability to process map site requirements using tools like Microsoft Visio
• Experience working with site SMEs to convert paper batch records to Electronic Batch Records (EBRs) in Rockwell Pharma Suite using standard functionality
• Ability to migrate existing EBRs from legacy systems (P2C2, PMX, etc.) into Rockwell Pharma Suite
• Skilled in designing reusable Building Blocks (BBs) for multiple processes
• Ability to author requirements, specifications (SPEC), and validation documentation
• Competency in performing full E  functional testing in a compliant manner
• Comfortable working in a fast-paced, agile team environment

• Participate in fit-gap analysis, process modeling, and process standardization with area leads and process SMEs
• Collaborate with lead Requirements Analysts (RAs) to define Building Block requirements
• Provide time estimates, story point estimates, and status updates for assigned work items
• Author and execute validation documentation for EBRs
• Configure EBRs across Development, Stage, and Production environments
• Address site-specific questions, use cases, and enhancement requests related to EBRs and product ownership
• Work cross-functionally to gather detailed requirements for enhancement requests (ERs)
• Provide Hyper Care and Go-Live support during deployments