SAP QA Tester Remote Location
Posted 1 day ago by 1763272896
Negotiable
Outside
Remote
USA
Summary: The SAP QA Tester role involves providing quality oversight for GxP computerized systems, ensuring compliance with regulatory expectations and company policies. The position requires strategic direction for SDLC deliverables, leading quality reviews, and managing risk-based validation strategies. Additionally, the role includes mentoring quality staff and fostering collaborative partnerships while driving quality practices within Agile teams.
Key Responsibilities:
- Provide quality oversight for GxP computerized systems across programs, including ownership of audit and inspection support and remediation activities.
- Provide strategic direction and governance for SDLC deliverables, leading comprehensive, risk-based quality reviews using the Computer System Assurance (CSA) framework.
- Define, approve and champion risk-based validation strategies and test plans for functional and regression testing.
- Lead root cause analysis and investigations for IT system incidents, drive CAPA development and ensure timely closure and verification.
- Serve as subject-matter lead on Data Integrity: interpret guidance, direct remediation activities, and ensure lasting controls are implemented.
- Drive testing strategy and quality practices within Agile teams, represent quality in Scrum ceremonies and ensure quality requirements are embedded from inception.
- Oversee review and approval of IT system change requests, ensuring appropriate documentation, traceability and regulatory compliance.
- Authorize and/or revise SOPs, work instructions and quality documentation, coach teams on compliant documentation practices.
- Lead cross-functional meetings to resolve compliance issues, escalate as needed, and ensure timely resolution of document comments and findings.
- Act with independence, objectivity and accountability, mentor quality staff and foster collaborative, innovative cross-functional partnerships.
Key Skills:
- Proven experience with SAP S4HANA or ECC for GxP functionality, including data migration, qualification of migration tools, and interface, reports validation.
Salary (Rate): undetermined
City: undetermined
Country: USA
Working Arrangements: remote
IR35 Status: outside IR35
Seniority Level: undetermined
Industry: IT
West Point PA
Job Description:
>> Provide quality oversight for GxP computerized systems across programs, including ownership of audit and inspection support and remediation activities and ensure compliance with company policies, procedures, and regulatory expectations.
>> Provide strategic direction and governance for SDLC deliverables, leading comprehensive, riskbased quality reviews using the Computer System Assurance (CSA) framework.
>> Define, approve and champion riskbased validation strategies and test plans for functional and regression testing.
>> Lead root cause analysis and investigations for IT system incidents, drive CAPA development and ensure timely closure and verification.
>> Serve as subject-matter lead on Data Integrity: interpret guidance, direct remediation activities, and ensure lasting controls are implemented.
>> Drive testing strategy and quality practices within Agile teams represent quality in Scrum ceremonies and ensure quality requirements are embedded from inception.
>> Oversee review and approval of IT system change requests, ensuring appropriate documentation, traceability and regulatory compliance.
>> Authorize andor revise SOPs, work instructions and quality documentation coach teams on compliant documentation practices.
>> Lead crossfunctional meetings to resolve compliance issues, escalate as needed, and ensure timely resolution of document comments and findings.
>> Act with independence, objectivity and accountability mentor quality staff and foster collaborative, innovative crossfunctional partnerships.
Requirements:
>> Proven experience with SAP S4HANA or ECC for GxP functionality, including data migration, qualification of migration tools, and interface, reports validation.