Denmark Job Openings
Skillspark AB
Workstream Lead – Test & validation
Copenhagen
FULL TIME
August 29, 2024
Key Responsibilities:
-
Responsible for defining and executing Validation and qualification strategy for Gx P Computerized Systems, including end-to-end validation and qualification activities including making a Validation (implementation) plan, Validation (Implementation) report, Design Review, Test strategy and execution etc.
-
Ensure Pharmaceutical Gx P requirements for IT and LOB processes are implemented and guidelines provided to the relevant stakeholders
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Responsible for ensuring that supply chain systems are in compliance with relevant internal and external regulatory requirements when introducing the new order flow changes
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Periodically align with IT QA and LOB QA as primary stakeholders
-
Facilitate all test activities, identifying test scope, provide tools, processes and training required for optimal testing
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Plan, track and report on testing and validation activities progress
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Be the main point of contact for this workstream and resource management within workstream
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Manage and manage workstream progress according to Project Implementation plans
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Help solve impediments, Identify & escalate workstream constraints, issues and risks
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Work with following resources within the workstream:
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Specification writers, if needed based on specification strategy and workload
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Test Manager, if needed based of testing and validation strategy
-
IT QC
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Specification writers, if needed based on specification strategy and workload
-
Have experience in leading a Validation track in a project setup
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Pharma industry knowledge is required with experience in implementation regulatory requirements (GAMP5) for IT systems and processes
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Well versed in project management methodology and principles
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Able to handle complexity and stakeholder management skills
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Able to author leading project documentation
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Culturally adept with international background
End Date: 12 months
Allocation: Full time, time and material
Location: Bagsværd, Denmark (Hybrid)
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