Natalia Nowacka

Experience

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  IBM

  Jul 2013 - Sept 2021

  Quality Manager for Astellas regulated account. • extensive GxP pharmaceutical skills & experience and detailed knowledge of FDA Compliance processes,• advise the Project Managers team on Qualification best practices,• support and drive Infrastructure qualification and validation activities,• advise project teams on qualification and validation approach for infrastructure components/validation of applications,• liaise with Astellas IT Compliance and or Quality Assurance to agree on qualification approach for project components/validation of applications,• review and approve qualification and validation life cycle document, Show less Process Quality Manager for Novartis regulated account.・ Execute the internal assessment program for GxP and SOX controls reporting monthly to Management and the Customer the results of the assessments and status on remediation actions,・ Execute internal assessment testing as agreed with the customer - This includes developing test script, leading the testing, work with the SME on RCAs,・ Working with the customer, IBM Compliance, and the IBM Delivery Team determine appropriate remediation of any findings resulting from the internal assessment. Track to ensure remediation activities are performed on time,・ Work closely together with the customer Quality Managers,・ Ensure the correct templates for all regulatory quality & compliance documents (IQs, OQs, Test Plan, Test Scripts, etc.) are being used and provide guidance to the teams about the quality guidelines to develop the right documentation,・ Work with the Process Owners as they produce process documents to ensure Quality and Compliance requirements are incorporated,・ Review completed quality & compliance documents for compliance with GxP requirements,・ Provide formal sign off of quality & compliance documents,・ Review the executed documentation and prove that the installer and the technical reviewer signatures are in place,・ Proactively coach Delivery Teams to increase the quality of the IQ/OQ records being filled out,・ Deviation Reporting & Monitoring,・ Identify opportunities for quality improvement,・ Support client and internal audits and assessments. Show less Execution Quality Manager for Novartis· Perform Quality Assurance on technical documentation produced during the qualification/validation of the IT systems.· Ensure the correct templates for IQs/OQs are being used.· Review the executed IQ/OQ documentation and prove they are filled out according to the “GoodDocumentation Practices” and that the installer and the technical reviewer signatures are in place.· Provide formal sign off of IQ/OQs (as required by the client).· Coach Delivery Teams to increase the quality of the IQ/OQ records being filled out.· Verify that the installers and technical reviewers are trained on the processes and procedures theyare executing.· Execute Quality and Compliance Assessments for all in-scope activities to ensure objectiveevidence of all quality and compliance controls are being followed is available.· Support client and internal audits and assessments. Show less

  • Quality Manager

    Dec 2017 - Sept 2021

  • Process Quality Manager

    Jan 2014 - May 2018

  • Junior Business Compliance Specialist

    Jul 2013 - Jan 2014
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  Kyndryl

  Sept 2021 - Nov 2024

  Quality Manager

  Quality Manager for Astellas regulated account. • extensive GxP pharmaceutical skills & experience and detailed knowledge of FDA Compliance processes,• advise the Project Managers team on Qualification best practices,• support and drive Infrastructure qualification and validation activities,• advise project teams on qualification and validation approach for infrastructure components/validation of applications,• liaise with Astellas IT Compliance and or Quality Assurance to agree on qualification approach for project components/validation of applications,• review and approve qualification and validation life cycle document, Show less

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  Boehringer Ingelheim

  Nov 2024 - now

  Validation Specialist