eCSV Senior Compliance Advisor

About the Role

The eCSV 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.

Key Responsibilities:

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 eCSV 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 eCSV 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:

• Minimum 2 years of experience managing equipment/process validation lifecycles, including validation documentation development.

• Minimum 2 years of experience in pharmaceutical manufacturing or the medical device industry, working in computer systems validation, process validation, quality assurance, or compliance functions.

• Strong understanding of equipment and process validation principles and methodologies.

• Good engineering background with a focus on equipment and process validation.

• Understanding of production equipment controlled by PLCs within manufacturing environments.

• Strong knowledge of GxP regulations, industry standards, and best practices, including 21 CFR Part 820, 21 CFR Part 11, EU Annex 11, and GAMP.

• Demonstrated experience managing complex validation projects and maintaining validation requirements for computerized systems supporting healthcare products.

• Experience with electronic systems and applications, including Electronic Document Management Systems (EDMS), Product Lifecycle Management (PLM), Quality Management Systems (QMS), Laboratory Information Management Systems (LIMS), Complaint Management Systems (CMS), and Enterprise Resource Planning (ERP) systems.

• Excellent communication and presentation skills, with the ability to effectively convey compliance requirements to stakeholders at all levels.

• Strong written communication skills, including the development and review of validation and compliance documentation.

• Ability to influence, negotiate, and constructively challenge stakeholders to achieve effective and compliant solutions.

• Ability to rapidly adapt to new situations and changing business environments.

• Strong organizational skills with the ability to manage multiple priorities and workstreams effectively.

• Conscientious and highly committed, with a strong dedication to quality and continuous improvement.

Qualifications/Education:

• Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related field.

Travel Requirements:

• Position may involve travel up to 10% of the time, mostly within Europe.

Working Conditions:

• Hybrid working model with flexibility required to meet project and business needs.

• Primary location is Deeside, with occasional travel to our Rhymney site.

• On-site presence will vary depending on project requirements and may range from predominantly remote working to full-time on-site attendance during key project phases.

• Candidates should be comfortable with a flexible working pattern and site presence as required.

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