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 PharmaSuite using standard functionality
Ability to migrate existing EBRs from legacy systems (P2C2, PMX, etc.) into Rockwell PharmaSuite
Skilled in designing reusable Building Blocks (BBs) for multiple processes
Ability to author requirements, specifications (SPEC), and validation documentation
Competency in performing full EBR functional testing in a compliant manner
Comfortable working in a fast-paced, agile team environment
Roles & Responsibilities
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 HyperCare and Go-Live support during deployments