Job Title: Business Analyst with Release Management
Location: Woodside, CA (Hybrid / REMOTE)
Contract Duration: 6 Months
Compensation: $53.00/hr (W2)
Position Overview
We are looking for a Business Analyst with expertise in Release Management and GMP Validation to support the Spark Integration project. This role focuses on developing validation strategies for QMS replacement (Veeva Spark to Veeva Roche) and ensuring digital solutions—including data pipelines, automation apps, and statistical tools—comply with Roche internal standards and GxP requirements.
Key Responsibilities
* Validation Strategy: Develop and implement validation strategies for Spark Integration and QMS replacement.
* Documentation: Create validation plans, protocols, and reports for data-driven models and automation applications.
* Risk Management: Conduct risk assessments for digital solutions used within GMP environments and develop mitigation strategies.
* Testing & Qualification: Partner with QA SMEs to align testing activities with Roche standards and document test findings.
* Compliance: Ensure all activities adhere to data integrity guidelines and GMP regulatory requirements.
* Collaboration: Coordinate with IT Business Partners, Product Owners, Architects, and external vendors to harmonize business processes.
* Release Management: Manage Release Management processes and controls for business/end-user applications.
Required Qualifications
* Experience: Project-based experience in the pharmaceutical industry (Technical Operations, Manufacturing, or Logistics).
* Core Expertise: Strong knowledge of validation principles and practices in a GMP environment.
* Technical Literacy: Understanding of SDLC models, Release Management controls, and test automation.
* Systems Knowledge: Prior experience with Veeva or patient/physician portals is a plus.
* Skills: Ability to write technical validation documentation and explain complex concepts with clarity.
* Education/Language: BE/BA degree; fluent in written and spoken English.
Raja
Technical Recruiter | ASCII Group, LLC,
,
38345 W 10 Mile Rd, Suite 365, Farmington, MI 48335, US,
[](
Never miss an opportunity! Create an alert based on the job you applied for.
