Cloudious LLC
Sunnyvale, CA
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Job Description :
Job Title : Business Analyst with Pharma Domain
Work Location : Waco, TX
Hiring Mode : Full Time / Contract to Hire
Job Description:

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