Our Client is seeking an experienced Validation professional in the San Francisco Bay Area. The Quality Engineer supports work stream efforts for projects below. The QE will support validation activities and prepare documentation that meet our Client’s internal standard operating procedures. Activities will include acting as Validation Engineer on GxP Learn project (Client’s Learning Management System) and Authoring, reviewing, and approving Validation work stream deliverables, including, but not limited to:
- Business Process Diagrams
- Validation Plan
- User Requirements Specification
- Functional Requirements Specification
- Design Specification
- Installation Qualification Protocol
- Operation Qualification Protocol
- Performance Qualification Protocols
- Data Migration Protocols
- Traceability Matrix, Summary Reports
- Standard Operating Procedure
- Documenting, investigating, reviewing, and approving Issue Reports
- Dry-running and executing test protocols
- Conducting Requirements Risk Assessment
Knowledge Requirements:
- Contributes to the development of validation concepts, techniques, and approach.
- Problem Solving: Develop solutions to complex problems which require the regular use of ingenuity and innovation.
- Ensures solutions are consistent with organization objectives.
- Discretion/ Latitude: Work is performed without appreciable direction. Exercises some latitude in determining objectives and approaches to assignment.
- Liaison (Internal & External Influence): Serves as consultant to the Project Core Team (members consists of QA, Business Process Owners, and System Manager), and moderate matters pertaining to the validation work stream.
Specific Requirements
- 6-12 years of strong Computer Systems Validation Experience
- Experience in Regulations (e.g. Part 11, Annex 11, cGMP, GAMP 4)
- Experiences with Risk Based Approach
- Experience in SaaS and ComplianceWire Learning Management System (preferred but not required)
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