Business Analyst

Hi,

This is Sanchit Verma, A Technical Recruiter with Diverse Lynx, I am trying to reach you regarding one open position.

Role: Business Analyst

Location: Remote

Job Type: Contract

Job Description: We are seeking a Business Analyst to support the Spark Integration Project, including QMS Replacement (Veeva Spark to Veeva Roche). The role focuses on validation strategy, compliance, risk assessment, and cross-functional collaboration within a GMP-regulated pharmaceutical environment.

The ideal candidate will have strong validation experience in digital solutions, a solid understanding of GxP requirements, and experience working within pharmaceutical technical operations systems.

Key Responsibilities

Validation Strategy

• Develop and implement a validation strategy for Spark Integration and QMS Replacement initiatives.

• Ensure alignment with regulatory requirements, industry best practices, and Roche internal standards.

   

Validation Planning & Documentation

• Create and manage validation plans and protocols for digital solutions including:
  • Data pipelines and system interfaces
  • Automation applications
  • Data-driven models and statistical tools

• Ensure proper execution and documentation of all validation activities.

   

Risk Assessment & Mitigation

• Conduct risk assessments related to digital solutions used in GMP environments.

• Develop and implement appropriate mitigation strategies and controls.

   

Testing & Qualification

• Ensure testing activities align with Roche standards.
• Partner with QA SMEs to:
  • Execute test cases
  • Analyze results
  • Document findings

• Support release management processes and controls.

   

Compliance & Governance

• Ensure compliance with GMP and data integrity guidelines.
• Maintain accurate validation documentation including:
  • Validation plans
  • Protocols and reports

  • Change control documentation

     

Collaboration & Communication

• Collaborate with:
  • IT Business Partners
  • Product Owners
  • Developers and Testers
  • IT Architects
  • Adoption Services
  • External Vendors
• Manage communications across multiple business units and cross-functional IT teams.

• Promote harmonization of business processes through standardized data models, applications, and technologies aligned with enterprise informatics strategies.

   

Continuous Improvement & Leadership

• Identify opportunities to improve processes, tools, and organizational effectiveness.
• Take initiative in professional growth and assume squad lead roles when appropriate.

• Demonstrate strong business partnering and/or product management capabilities.

   

Required Qualifications

• Strong understanding of Software Development Life Cycle (SDLC) models.
• Proven experience validating digital solutions in a GMP-regulated environment.
• Deep knowledge of GxP requirements and documentation standards.
• Experience with:
  • Release management processes and controls
  • Test automation processes and development
• Project-based experience in the pharmaceutical industry.
• Experience implementing Technical Operations Systems and Equipment.
• Familiarity with:
  • Manufacturing processes
  • Quality systems
  • Intercompany order processing
  • Outbound logistics
• Ability to write validation documentation.
• Detail-oriented with high accuracy.
• Ability to explain complex technical concepts clearly and concisely.
• Strong communication and stakeholder management skills.
• Ability to work independently and proactively improve ways of working.

Sanchit Verma

Technical Recruiter

Diverse Lynx LLC

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