Quality Assurance Engineer/SAP Data Quality - Eindhoven - 8 Months

Quality Assurance Engineer/SAP Data quality - Eindhoven - 8 months

We are looking for a Quality Assurance Engineer SAP for an 8 month contract in Eindhoven. You need Solution Manager and ChaRM experience to fulfil this role. This would ideally suit someone locally or with good flight connections to Eindhoven.

Please read carefully the position before applying for this role, as the client is being very specific.

WE ARE LOOKING FOR:

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IT Software Development Experience Preferred - SAP
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Must have 5+ years of experience as a Software Quality Assurance Engineer, and 10+ of experience in Software Life Cycle Process Development
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Understanding of transition from a traditional SAP implementation to cloud is preferred (SAP HANA Cloud Platform), as the Overall program is the simplification & standardization of an ERP backbone based on SAP.
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Must have experience in SAP consolidation and Deployment across major world geographic areas as it relates to SQA role and responsibilities.
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Must have 3+ experience in SAP validation planning and execution.
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Must have experience in validating and maintaining a set of applications on an ERP backbone in a validated state, using SolMan (and ChaRM) for Change Control
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Management and Validation Deliverables.
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Good communication skills in a must, and ability to describe validation requirements clearly, concisely and in a convincing manner.
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Demonstrated ability to interact and communicate (both oral and written) with junior project team/organizational members, business leaders and senior executives.
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Experience as an SAP Project manager is a plus but not required
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Engineering degree in computer Science is preferred
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Experience working in disciplined regulated industry in the application of automated technology particularly 21 CFR, ISO 13485, GAMP 5

YOUR RESPONSIBILITIES

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Enforce policies and procedures for System Life Cycle control for use in Healthcare across all automated processes that drive, interface with, and provide data for the Quality System.
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Support development of the validation strategy and the validation effort from planning to retirement of SAP based QMS applications and tools including interfaces to and from the system.
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Provide subject matter expertise during regulatory and partner inspection.
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Provide software quality assurance support in design and development of software solutions, and facilitate the application of controls and risk management by reviewing and approving IT change-control requests submitted by cross-functional project teams to assess potential quality system impact.
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Ensure that system development projects and changes to existing systems are conducted in compliance with the FDA Quality System Regulation
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Work alongside other validation professionals to gather data, plan activities, and obtain reviews and approvals of documentation including approving documentation with respect to software development life cycle policies and procedures.
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Assist in developing user, functional and technical requirements for IT systems.
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Provide guidance and support to personnel in their validation efforts, to ensure compliance.
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Provide GxP-related quality assurance oversight, with an emphasis on software validation.
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Track system life cycle deliverables and activities to ensure that regulations, protocols, procedures, and methodologies are followed, and that appropriate and complete documentation is captured and reported to support validation activities.
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Represent Quality & Regulatory Compliance and Control on cross-functional teams in support of activities.
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Advise technical personnel and management on regulatory compliance and interpretation and recommend appropriate corrective actions where needed.

If you are interested, please send in your updated CV to discuss.