Job Description :
Please share resume at amit dot kumar at nityo dot com

Job title : Business Analyst
Location : Waco, Texas
Job Type : Fulltime

Client is looking for a business analyst , who could help them in creating process SOPS, URS/FRS for all the system, following SDLC, under technology up gradation program.

Mandatory Skills:
1.Minimum 9-10 years’ experience in business analysis or a related field. Understanding of OS manufacturing IT is preferred.
2. Techno Functional knowledge & experience of ISA 95 stack & various industrial automation and manufacturing application preferably with in Pharma industry
3. Exposure to computer system validation (CSV) is must
3. Skills : Business process mapping & analysis

Preferred Skills:
Experience in Writing URS/FRS, SOPs, trainings
Interviewing stakeholders & SMEs

Job Role:
Lead discussions with business, quality, information system to understand various GMP manufacturing applications/automation systems
Gathering both technical and non-technical requirements, developing business process analysis, user/systems requirement analysis and specifications.
Participate in internal and external meetings relating to projects; provides summaries of meeting to appropriate person(s) and makes recommendations as appropriate.
Support processes to meet 21CFR Part 11 and Annex 11 standards to effectively manage information flow, data collection, and review activities.
Create, modify, and manage Standard Operating Procedures (SOPs), Work Instructions, and Risk Assessments, related to GMP systems.
Lead validation effort to perform validation/qualification activities to ensure data integrity and GMP system compliance.