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Business Systems Analyst

hace 2 meses

Tijuana, Baja California, México flex A tiempo completo
About the Role

We are seeking a highly skilled Business Systems Analyst to join our team at Flex, a leading diversified manufacturing partner. As a key member of our team, you will play a critical role in supporting our extraordinary teams who build great products and contribute to our growth.

Key Responsibilities
  1. Analyze and Improve Business Processes: Utilize industry trends and professional business knowledge to analyze current business processes and make recommendations for improvement.
  2. Software Validation and Compliance: Ensure compliance with 21 CFR Part 11, Electronic Records; Electronic Signatures, and 21 CFR Part 820, as well as GAMP5 and ISO13485 standards.
  3. Manufacturing End-to-End Process Interpretation: Apply and run software validation tasks and activities to ensure seamless manufacturing processes.
  4. Software Quality Reviews and Systems Audits: Conduct thorough reviews and audits to ensure software quality and compliance.
  5. Risk Management and Compliance: Identify and mitigate risks, ensuring adherence to GxP standards and regulations.
Requirements
  1. Intermediate English Proficiency
  2. Software Validation and Compliance Expertise: Proven experience in software validation and compliance with 21 CFR Part 11, ERES, Part 820, and GAMP 5.
  3. Software Quality Engineer: Collaborate with validation engineers to complete validation documents and review and sign SIQ, Verification, Validation Protocols, and Reports.
  4. SDLC Methodology: Apply a risk-based approach to software validation using SDLC methodology.
  5. Computerized Systems Validations: Conduct validations of computerized systems.
  6. ERP System Validation: Validate ERP systems.
  7. GAMP5, 21 CFR Part 11, ERES, 21 CFR Part 820, and ANSI/AAMI/IEC 62304: Possess working knowledge of these standards and regulations.
What We Offer
  1. Pantry Vouchers
  2. Saving Fund
  3. Christmas Bonus
  4. Holiday Bonus
  5. Medical Insurance
  6. Life Insurance

Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We celebrate diversity and do not discriminate based on age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law.