CSV Senior Compliance Advisor

About Convatec

Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With more than 10,000 colleagues, we provide our products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec’s revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit http://www.convatecgroup.com

Key Responsibilities:

The CSV Senior Compliance Advisor will oversee GxP impacting projects to ensure that all applicable regulatory and compliance requirements are met for any new or revised computerized systems to ensure that these systems are not only defendable during an inspection, but also confirm that the delivered systems/services are fit for purpose by meeting user requirements. Focus on Laboratory equipment and test equipment in manufacturing area.

Your Contributions (include, but are not limited to):

Implementation Projects

• Evaluate proposed new computerized systems or software to assess GxP impact and where GxP impact is identified provides guidance on the risk-based validation approach for the system
• Work closely with the Project manager to ensure all compliance milestones are met during the project lifecycle.
• Oversee and/or assists in the development of validation deliverables including Validation Plans, Test Plans/Protocols/Scripts, Specifications and Design Documents, Compliance Assessments, Risk Assessments, Installation Qualification, System and User Acceptance Testing, Data Migration Plans, Traceability Matrices, Validation Reports, Supplier Assessments, etc.
• Prepare, or review and approve major system documentation to ensure consistency with quality standards and quality of deliverables.
• Establish and maintain standards and training materials for the specification, design, development, configuration, implementation, validation, use and maintenance of computerized systems which support the development, manufacture and distribution of products in alignment with applicable company policies and regulations.
• Coach the implementation teams in the proper execution of validation documents
• Manage formal testing of computerized systems including, setup of testing, documentation, approval, delivery, and test reporting.
• Solve problems during validation process and address/advise on issues such as deficiencies, deviations, and change controls. Ensure initiation/preparation and closeout of all CSV related deviations.
• Supply accurate KPIs to management on Project compliance status
   

System Maintenance

• Review proposed changes to validated computer systems/qualified IT infrastructure and identify the validation or qualification requirements necessary to maintain the validated/qualified state after execution of the change.
• Ensure all changes are implemented and documented in a compliant manner.
• Perform periodic assessment to review and confirm validated status.
• Perform periodic re-validations.

Quality Management

• Ensure initiation/preparation and closeout of all CSV related deviations, discrepancies and change control documents.
• Conduct Quality Reviews to evaluate if processes and deliverables fulfil the requirements for quality, to uncover errors or deficiencies in processes and deliverables, and to identify strengths and opportunities for improvement.
• Follow up resolution of identified quality exposures and escalation to team lead if critical situations are not resolved in due course.
• Ensure that suppliers of IT services and solutions are properly assessed to determine their level of competence and reliability, and ensure the organization employs appropriate risk based approaches to delivery taking into account the output of the supplier assessment.
• Maintain up to date knowledge of evolving regulatory requirements, availability of current/new techniques, and literature regarding compliant computer systems, and acts as an information resource for the delivery teams and wider business.

Skills & Experience:

• Strong understanding of GXP Regulatations and best practice (21CFR820, 21CFR11, Annex 11, GAMP,  etc.)

• Demonstrated experience in successfully managing complex validation projects and maintaining the validation requirements for computerized systems supporting healthcare products.
• Detailed understanding of computer system validation and infrastructure qualification, including the application of risk managed approaches.
• Experience in electronic software applications such as Electronic Document Management System (EDMS), Product Lifecycle Management (PLM), Quality Management Systems (eQMS), Complaint Management Systems, Enterprise Resource Planning systems (ERP), etc.
• Ability to rapidly adapt to new situations and environments.
• Excellent communication skills with the ability to effectively convey compliance requirements at all levels.
• Ability to influence, negotiate, and constructively challenge to achieve productive solutions.
• Ability to handle a high concentration of work through successful multitasking & prioritizing.
• Conscientious and highly committed, with a dedication to quality.
• Advanced conversational english level.

Qualifications/Education:

Bachelor’s degree in computer science, engineering life science or related field plus 5 years experience with CSV validation lifecycle management, validation documentation development. 2 plus years pharmaceutical manufacturing or Medical Device industry experience in computer systems validation, process validation, QA or compliance functions. Excellent understanding and experience with industry regulations, standards, and guidelines, e.g., GxP, validation, 21 CFR Part 11, etc. Excellent presentation and writing skills.

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