What are the responsibilities and job description for the Validation Lead with Oracle Process Manufacturing -(Healthcare domain) position at Gurus Infotech, Inc.?
Job Details
Role :- Validation Lead with Oracle Process Manufacturing (OPM)
Location :- Chicago, IL-Onsite
Duration :- 12 Months
Role Overview:
- We are seeking a skilled Validation Testing Specialist with deep expertise in Oracle Process Manufacturing (OPM) to support validation efforts across manufacturing systems.
- The ideal candidate will ensure compliance with regulatory standards and deliver high-quality validation documentation and testing outcomes.
Key Responsibilities:
- Lead validation testing activities for Oracle Process Manufacturing modules including recipe management, batch processing, and quality control.
- Develop and execute validation protocols (IQ/OQ/PQ) aligned with CSV and CSA methodologies.
- Ensure compliance with ICH Q9 Guidelines and other relevant regulatory frameworks.
- Collaborate with cross-functional teams to define test strategies and acceptance criteria.
- Perform integration testing with systems such as MES, ESB, and other enterprise platforms.
- Document test results, deviations, and corrective actions in accordance with SOPs.
- Support audit readiness and respond to inspection queries related to validation deliverables.
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