TechDigital Group
Mandatory Skills
Computer System Validation, Computed system assurance, GAMP, GxP risk assessments, Change Management. 12+ years' experience in validating systems and experience in CSV activities in GxP related applications like SAP systems, product serialization systems, MES systems. Responsibilities
Perform reviews for GxP systems to ensure compliance with regulatory requirements. Work with end-to-end validation of GxP applications and conduct document/process compliance analysis. Adept with Agile and Waterfall software development methodologies; prior experience in Computer System Validation using Agile methodology. Prepare and manage validation activities including: Requirements Specifications Functional Specifications / User Stories / Acceptance Criteria Ensure completeness of test scripts with traceability Ensure risk assessment is completed for all requirements and that test cases are designed with reference to identified risk levels Review pre-executed test protocols for completeness and appropriateness of tests Ensure test data requirements are defined to run tests Review post-execution test protocols for completeness and accuracy of results; manage defects Author Validation Plan and Validation Summary Report; compile RTM; review that Operational Procedures are ready Handle change requirements for small changes: responsibility for Implementation Plan, Impact Assessment, Test Plan/Results, Defects and RTM Experience with tools such as ALM, DMS and JIRA Experience in implementing US-DSCSA is a plus Role and Engagement
Single point of contact for Geo and functional scope of services related to system assurance and compliance, including CSA, Validation SME and test management. Responsible for geo and functional service quality, performance and customer satisfaction; demand management. Perform CSL roles such as CSA, Validation SME, and Test Manager as required by CSL QMS. Build and manage relationships with regional stakeholders, including gathering and resolving feedback. Review system assurance and compliance deliverables and guide the team on a daily basis.
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Computer System Validation, Computed system assurance, GAMP, GxP risk assessments, Change Management. 12+ years' experience in validating systems and experience in CSV activities in GxP related applications like SAP systems, product serialization systems, MES systems. Responsibilities
Perform reviews for GxP systems to ensure compliance with regulatory requirements. Work with end-to-end validation of GxP applications and conduct document/process compliance analysis. Adept with Agile and Waterfall software development methodologies; prior experience in Computer System Validation using Agile methodology. Prepare and manage validation activities including: Requirements Specifications Functional Specifications / User Stories / Acceptance Criteria Ensure completeness of test scripts with traceability Ensure risk assessment is completed for all requirements and that test cases are designed with reference to identified risk levels Review pre-executed test protocols for completeness and appropriateness of tests Ensure test data requirements are defined to run tests Review post-execution test protocols for completeness and accuracy of results; manage defects Author Validation Plan and Validation Summary Report; compile RTM; review that Operational Procedures are ready Handle change requirements for small changes: responsibility for Implementation Plan, Impact Assessment, Test Plan/Results, Defects and RTM Experience with tools such as ALM, DMS and JIRA Experience in implementing US-DSCSA is a plus Role and Engagement
Single point of contact for Geo and functional scope of services related to system assurance and compliance, including CSA, Validation SME and test management. Responsible for geo and functional service quality, performance and customer satisfaction; demand management. Perform CSL roles such as CSA, Validation SME, and Test Manager as required by CSL QMS. Build and manage relationships with regional stakeholders, including gathering and resolving feedback. Review system assurance and compliance deliverables and guide the team on a daily basis.
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