US-CA-SanFrancisco: SQA Analyst
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please visit http://sqa.fyicenter.com
Sr. SAP Validation & SQA Analyst
? Assists in the development, planning, directing and tracking of the validation of computer systems supported by SAP & Reporting team (i.e. SAP ERP, BW, APO, XI, Solution Manager, GRC, Portal and Business Objects)
? Maintains production computer systems in a validated state, monitors all modifications or changes to systems or processes, initiates change control / revalidation as required and ensures a continual state of inspection readiness with regard to cGMPs.
? Works with project teams to come up with validation strategies for projects and works closely with project managers to meet the timelines. Develops and writes validation project plans, master validation protocols, traceability matrices and summary reports by providing instructions and scientific rationale for the performance of validation studies.
? Leads fellow technical and analysis team members in ensuring compliance with corporate quality standards and requirements. Facilitates the translation of new and revised corporate quality requirements into practical application for revising, updating and adding new documentation to an existing computer system validation package.
? Coordinates the testing efforts of the IT and business teams with regards to requirements, resource planning, test coverage, test strategies. Advises the business SMEs and IT Applications staff to create thorough, accurate and comprehensive test scripts. Develops and maintains test metrics and generate reports for management use in determining project and applications test status.
? Coordinates and interacts with all affected personnel in the execution of test scripts and validation protocols and gathering of test data. Ensure all protocol executions are documented and recorded in accordance with company quality policies, quality standards and SOPs. Analyzes data to determine if it meets protocol acceptance criteria and document deviations as necessary. Ensure all final reports are documented and approved.
? Recommends methods for process improvement, detailing process strengths and weakness of existing and proposed procedures and controls
? Participate in internal and external vendor audits and regulatory audit teams.
? Maintain accountability for completion of required training for the position.
Who you are
? Minimum of 3 years of experience in validation of SAP systems and software testing in Pharmaceutical or Bio-Tech industry is required (regulated by government agencies, i.e. FDA, EMEA, Japan Health Authorities, Canadian Healtth Authorities, etc).
? Participation in at least one full life-cycle SAP implementation and production support is required.
? Good understanding of FDA regulations pertaining to computer systems validation (CFR Part 11) and cGMPs is required.
? Exceptional interpersonal, writing and communication skills and dedication to customer service and satisfaction are essential.
? Experience participating in external regulatory audit/inspection teams is preferred.
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Team SQAFYI - Software QA Resource FYI