Understand pharmaceutical manufacturing processes, especially Solid Oral Dose and Packaging.
Create Electronic Batch Records (EBRs) from paper-based batch records using Rockwell PharmaSuite, leveraging existing functionality.
Design reusable Building Blocks (BBs) that can be applied across multiple processes.
Participate in Fit-Gap Analysis, Process Modeling, and Process Standardization with SMEs and area leads.
Author and review requirements, functional specifications, and validation documentation (URS, FS, DS, OQ/PQ).
Validate EBRs and support configuration across environments (Development, Stage, Production).
Address site-specific queries, use cases, and enhancement requests (ERs).
Collaborate across teams to define requirements and support ER development.
Provide HyperCare and Go-Live Support post-implementation.
Estimate timelines, story points, and status updates for assigned work items.
Skills & Tools Required:
Rockwell PharmaSuite MES
Microsoft Visio (or similar) for process mapping
Good Documentation Practice (GDP) and Good Testing Practice (GTP)
Experience in EBR validation in a GMP-compliant environment
Knowledge of Agile methodologies (scrum/story points)
MES configuration experience across environments
Testing & compliance for pharmaceutical software solutions
Good to Have:
Experience in handling Electronic Records (ER) and system integration
Background in regulated pharmaceutical IT or manufacturing systems
Generic Managerial Skills:
Quick learner with strong self-drive
Strong interpersonal and mentorship skills
Able to work in fast-paced, cross-functional, agile environments
Required Skills for PharmaSuite Recipe Designers Job