eCSV Compliance Advisor

📋 Description

• • As a eCSV Compliance Advisor at ConvaTec Inc., you will play a pivotal role in ensuring that all computerized systems impacting GxP (Good Practice) processes meet stringent regulatory and compliance requirements. This remote position, based in Slovakia, is crucial for maintaining the integrity and reliability of systems that support the development, manufacture, and distribution of life-improving medical solutions.
• • Your primary responsibility will be to support GxP-impacting projects, ensuring that new or revised computerized systems are not only defensible during regulatory inspections but also demonstrably fit for purpose by meeting all user requirements. This involves a comprehensive understanding of validation principles and their application within a regulated industry.
• • During implementation projects, you will be tasked with evaluating proposed new computerized systems or software to assess their GxP impact. Where a GxP impact is identified, you will provide expert guidance on the most appropriate risk-based validation approach, ensuring that validation efforts are proportionate and effective.
• • You will collaborate closely with Project Managers to guarantee that all critical compliance milestones are achieved throughout the project lifecycle, fostering a proactive approach to regulatory adherence.
• • A key part of your role will involve assisting in the development and review of a wide range of validation deliverables. This includes, but is not limited to, Validation Plans, Test Plans, Test Protocols, Test Scripts, Specifications, Design Documents, Compliance Assessments, Risk Assessments, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), System Acceptance Testing (SAT), User Acceptance Testing (UAT), Data Migration Plans, Traceability Matrices, Validation Reports, and Supplier Assessments.
• • You will be responsible for preparing, or reviewing and approving, major system documentation to ensure it consistently aligns with company quality standards and maintains a high quality of deliverables.
• • Establishing and maintaining robust standards and comprehensive training materials for the specification, design, development, configuration, implementation, validation, use, and maintenance of computerized systems will be a core function. This ensures that all personnel involved understand and adhere to applicable company policies and regulations.
• • You will act as a coach and mentor to implementation teams, guiding them in the proper execution of validation documents and fostering a culture of compliance.
• • Managing the formal testing of computerized systems is another critical aspect of your role. This includes the setup of testing environments, meticulous documentation, obtaining necessary approvals, overseeing delivery, and generating comprehensive test reports.
• • Problem-solving during the validation process is essential. You will address and advise on issues such as deficiencies, deviations, and change controls, ensuring the timely initiation, preparation, and closeout of all CSV (Computerized System Validation) related deviations.
• • You will be required to supply accurate Key Performance Indicators (KPIs) to management, providing clear insights into the compliance status of projects.
• • In terms of system maintenance, you will review proposed changes to already validated computerized systems or qualified IT infrastructure. You will identify the necessary validation or qualification requirements to maintain the validated/qualified state after the execution of any changes.
• • Ensuring that all changes are implemented and documented in a compliant manner is paramount. You will also perform periodic assessments to review and confirm the validated status of systems and conduct periodic re-validations as required.
• • Within Quality Management, you will ensure the initiation, preparation, and closeout of all CSV-related deviations, discrepancies, and change control documents. Conducting Quality Reviews to evaluate processes and deliverables against quality requirements, uncovering errors or deficiencies, and identifying opportunities for improvement will be a regular activity.
• • You will follow up on the resolution of identified quality exposures and escalate critical situations to the team lead if they are not resolved in a timely manner.
• • Ensuring that suppliers of IT services and solutions are properly assessed to determine their competence and reliability is crucial. You will ensure the organization employs appropriate risk-based approaches to delivery, taking into account the outcomes of supplier assessments.
• • Maintaining up-to-date knowledge of evolving regulatory requirements, current/new techniques, and literature regarding compliant computer systems is vital. You will act as an information resource for delivery teams and the wider business, staying ahead of industry trends and best practices.
• • You will also ensure compliance with legislative and internal Environmental, Health, and Safety (EHS) requirements and participate in the fulfillment of the company's EHS targets.