We are looking for Business Analyst who should have Pharma industry exp + Who worked in Laboratory exp or manufacturing of pharma products
- Minimum 9-10 years experience in business analysis or a related field. Understanding of os manufacturing IT is preferred.
- Techno Functional knowledge & experience of ISA 95 stack & various industrial automation and manufacturing application preferably with in Pharma industry
- Skills : Business process mapping & analysis
- Experience in Writing URS/FRS, SOPs, trainings
- Interviewing stakeholders & SMEs
- 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.
Preferred Skills: Experience in Writing URS/FRS, SOPs, trainings Interviewing stakeholders & SMEs
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Waco, Texas, United States
Contract Based |
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