Karolina Zygon

Experience

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  Environmental Scientifics Group

  Feb 2007 - Feb 2016

  Main duty: Administration and maintenance of Environmental Chemistry Quality System based on ISO17025 and MCERTS standards. This role involves:• Performance of Horizontal , Vertical and Test Witness Audits • PT Schemes administration • Monitoring of Non-conforming Work and its investigation• Creation of Non-conformance Reports• Creation and distribution of Controlled Documents• Generation of Weekly and Monthly Quality Reports • Review and Administration of Shewart QC Charts in both Excel and Oracle/SQL based systems including development of data transfer macros and amendments to the existing VB codes• Creation and administration of Equipment Database (Access) and Resource Map (Excel)• Supporting preparation of QC standards and creation of the Excel based request system• And last but not the least: Support and guidance to UKAS auditors on their annual visits Show less Main duty: Analysis of Organic contaminants in Soil, Water and Gas matrices using the following analytical methods: • HPLC with both UV and electrochemical detectors• GC FID Headspace • GC MS 8100 • GC MS P&T • GC MS Headspace As an analyst, I was responsible for analytical work by meeting appropriate standards (ISO 17025 and MCERTS), assuring the resulting data is accurate, precise and delivered in a timely manner.I organised, prioritised and monitored workload in alignment with the current objectives of the department and customer’s requirements. My duties also included routine and non-routine instrument maintenance along with the maintenance of all relevant records. Show less Main duty: Supervision of Team of Laboratory Technicians in Water and Soil Extraction Labs. This position involved receiving and logging samples into the Laboratory Information Management System (LIMS) and delegating responsibilities for all jobs due on each day. I supervised the progress of extractions and authorised all jobs completed, which then were passed to the Organic Analysis Department. During the day I would also monitor whether any required QC standards weren’t missing or gone out of date. I would arrange for the preparation of new standards or prepare them myself if necessary. My job also involved attendance of the daily production meetings and supporting the process of method development and consecutive implementation of new methods and standard procedures. This included sharing my knowledge with all members of the team by means of one to one or group training. During my time as a Shift Supervisor I was also trained as a First Aider and became an Emergency Deputy Co-ordinator Show less

  • Quality Systems Administrator

    Mar 2011 - Feb 2016

  • Analyst (Organics Analysis Lab)

    Mar 2008 - Mar 2011

  • Shift Supervisor (Organics Extraction Lab)

    Apr 2007 - Mar 2008

  • Laboratory Technician (Organics Extraction Lab)

    Feb 2007 - Apr 2007
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  Healthcare at Home

  Feb 2016 - Sept 2021

  Role objective: Provide support to the Head of Compliance and Audit in their capacity as Risk Manager. Maintain and enhance the Sciensus Document Management System (DMS) to support the Quality Management System across the organization, ensuring compliance with various regulatory requirements (e.g., GDP, GMP, WDA, CQC) and commitments (e.g., ISO standards). Collaborate with departmental leaders to improve business efficiency and assure that Quality Systems meet both internal and external quality regulations. Core Quality Systems include DMS, CAPA, Internal Non-Conformance, Change Control, Validation and Continuous Improvement. Main Tasks and Achievements:• Influencing Service Development: Successfully influenced internal stakeholders via early adaptation of modern technologies (i.e.: MS Teams), leading to enhanced operational effectiveness and improved quality (DMS KPIs, tasks management).• Relationship Building: Built and maintained strong relationships with colleagues across various departments, promoting collaboration and teamwork within the organization.• Training and Coaching: Effectively trained, educated, and coached Quality Systems users, contributing to their professional development and to overall quality culture.• External Audit Support: Actively supported frequent external audits, ensuring all relevant documents are available and in the best possible shape, thus reducing the likelihood of adverse audit findings. Show less Role objective: Supporting new Head of Quality in the development of all aspects of Quality Management System in readiness for ISO9001 accreditation.To ensure regulatory compliance and operational efficiency of all Quality Management Systems with emphasis on the Document Management System (DMS) by managing document lifecycles and providing training and technical assistance to maintain a streamlined document control environment. This role was also expanded to oversee self-inspection processes and supporting frequent regulatory and pharmaceutical audits ensuring that no critical findings are raised.Main Tasks and Achievements:• Input in development of the main elements of the Quality System including Self-Inspections, Deviations and Non-Conformances, CAPA, Change Control, Quality Management Review, Continuous Improvement.• Achievement of ISO9001 Accreditation for Healthcare at Home in November 2017• DMS Oversight and Maintenance: Generated monthly DMS KPIs, handled DMS-related inquiries, maintained system functionality, and managed document templates, licensing, and troubleshooting.• Document Control and Compliance: Conducted daily review and approval of submitted documents, archived outdated materials, and ensured DMS documentation was audit-ready (incl. managing the regulatory licenses library).• Training and User Support: Arranged training sessions for document owners and approvers, conducted follow-up meetings, and provided ongoing support to maintain compliance and process knowledge across teams.• Self-Inspection Management: Oversaw the self-inspection schedule, generated inspection KPIs, led self-inspection meetings, and performed assigned audits to uphold internal standards.• Audit and Committee Involvement: Supported client, supplier, and regulatory audits on demand; attended various SLT level committees actively contributing to process improvement discussions and DMS-related projects. Show less Role objective:The main objective of this role was to develop a new regulatory compliant Document Management System, while reconciling data with legacy arrangements across all business areas.Main Tasks and Achievements:• Developed a SharePoint-based Document Management System (DMS), incorporating DocRead for Sciensus, meeting regulatory requirements and supporting company-wide document control.• Managed data reconciliation and migration from legacy systems (MaaS360, QPulse, and old SharePoint) into the new DMS.• Oversaw qualification and validation stages of the DMS Project ensuring required functionality and compliance.• Conducted user training and managed DMS launch in January 2017, followed by ongoing DMS review, deviation reporting, and CAPA management.• Worked alongside IT to draft DMS Recovery Plan for BCP purposes.• Improvement of Document Compliance Ratio from 23% to 98% within a year of DMS go-live. Show less

  • Risk & Compliance Business Parter

    May 2019 - Sept 2021

  • Quality Systems Specialist

    Oct 2017 - May 2019

  • Quality Systems Administrator

    Feb 2016 - Oct 2017
• 

  Sciensus

  Sept 2021 - now

  Risk / Compliance Officer

  Role Objective:Support Senior Leadership in maintaining regulatory compliance at Sciensus Group through effective risk management, counter-fraud initiatives, and governance support. Implement the Counter Fraud Strategy to meet NHSCFA standards and address the new “failure to prevent fraud” offense. Enhance internal controls, oversee risk registers, and promote a proactive approach to compliance and risk mitigation.Main Tasks and Achievements:Risk Management:Professional Development: Completed the Institute of Risk Management's International Certificate in Enterprise Risk Management (ERM) and became IRMCert and an AIRMIC member.Collaborative Approach: Worked with Board Directors and Senior Leaders to develop a Sciensus-specific risk management framework.Risk Registers Optimization: Consolidated legacy risk registers and adapted Risk Management Software to ensure effective oversight of Group and Operational Risks.Network Development: Supported the Risk Champions Network and provided mentorship to enhance members’ skills and effectiveness.Fraud Prevention:Counter Fraud Champion: Nominated by the CFO and registered with NHSCFA to lead counter-fraud initiatives.Framework Development: Created a comprehensive framework addressing “failure to prevent” offenses and compliance with NHS counter-fraud standards.Strategy Implementation: Developed and promoted a Counter-Fraud Strategy and Policy, including eLearning courses and campaigns for International Fraud Awareness Week.Investigation Collaboration: Conducted investigations into fraud incidents with the Local Counter Fraud Specialist, enhancing prevention efforts and filing annual assertions.Rating Improvement: Successfully moved the company’s overall rating from amber to green within the first year.Crisis Management:Assisted in a gap analysis to identify weaknesses in the company's existing Business Continuity Planning and Crisis Management strategies. Show less