Flex Business Systems Analyst 

Mexico, Baja California, Tijuana 

175946451

In this role, you will be In-charge of for exploring complex business problems in order to solve them with automated, customized, developed and standardize systems implementations and solutions, also be in charge of designing details for automated systems and processes in order to make them more efficient. Also designing the framework and process, troubleshooting technical malfunctions, risk research working with stakeholders and delivering a solution that is viable and consistent.

What a typical day looks like:

• Research complex business problems and propose automated solutions to improve operations and processes efficiency.
• In charge of providing technical expertise in identifying, evaluating, and developing systems and procedures that are cost effective, to provide consultation to users related to automated systems
• Research, design and test new systems and system enhancements in line with the deliverables of site business/customer's requirements.
• Resolve required improvements on the systems & supervise its correct implementation to meet site business/customer’s requirements.
• Communicate with users to troubleshoot and resolve day to day system issues to ensure smooth operation.
• Software Validation. 21 CFR Part 11, Electronic Records; Electronic Signatures
• Software Validation following 21 CFR Part 820
• Manufacturing End to End Process interpretation and understanding to apply and run Software Validation task and activities
• Software Quality reviews and systems audits
• Software compliance and Gap assessments
• MES (Manufacturing Execution Systems) Validation (like FlexFlow, MES Pro or equivalent)
• Software Quality Assurance
• Risk Management
• GxP Standards and Compliance (GAMP5)
• Quality Systems Regulations (FDA)
• ISO13485 understanding and compliance for IT
• Failure Modes Analysis (FMEA)

The experience we’re looking to add to our team:

• Intermediate English
• Software Validation and compliance to 21 CFR Part 11, ERES, Part 820, and GAMP 5.
• Software Quality Engineer working with Validation Engineers to complete the validation documents and review and sign the SIQ, Verification, Validation Protocols and Reports.
• Use SDLC methodology for Risk based approach to software validation.
• Computerized Systems Validations
• ERP System Validation
• Working knowledge of GAMP5, 21 CFR Part 11, ERES, 21 CFR part 820, ANSI/AAMI/IEC 62304 Medical Device Software and System Development Life Cycle Process

What you’ll receive for the great work you provide:

• Pantry vouchers
• Saving Fund
• Christmas bonus
• Holiday bonus
• Medical Insurance

Required Skills:

Optional Skills: