eCSV Senior Compliance Advisor in Stone

Overview

The e CSV Senior Compliance Advisor will oversee Gx P impacting projects to ensure that regulatory and compliance requirements are met for new or revised computerized systems.

The role ensures systems are defendable during inspections and meet user requirements, delivering fit-for-purpose solutions.

Responsibilities

• Evaluate proposed new computerized systems or software to assess Gx P impact and, where Gx P impact is identified, provide guidance on risk-based validation approaches.
• Collaborate with the project manager to ensure all compliance milestones are met during the project lifecycle.
• Oversee and/or assist 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, and related artifacts.
• Prepare, review, and approve major system documentation to ensure consistency with quality standards and deliverables.
• Establish and maintain standards and training materials for specification, design, development, configuration, implementation, validation, use and maintenance of computerized systems supporting development, manufacture and distribution in alignment with policies and regulations.
• Coach implementation teams in the proper execution of validation documents.
• Manage formal testing of computerized systems including setup, documentation, approval, delivery, and test reporting.
• Solve problems during validation, and advise on deficiencies, deviations, and change controls; ensure initiation, preparation and closeout of all e CSV related deviations.
• Provide accurate KPIs to management on project compliance status.
• Review proposed changes to validated computer systems/qualified IT infrastructure and identify validation or qualification requirements to maintain the validated state after changes.
• Ensure all changes are implemented and documented in a compliant manner and perform periodic assessments to confirm validated status and re-validations where required.
• Conduct Quality Reviews to evaluate processes and deliverables against quality requirements, identify errors, and propose improvements.
• Assess suppliers of IT services and solutions for competence and reliability, applying risk-based approaches to delivery based on supplier assessments.
• Maintain up-to-date knowledge of regulatory requirements and best practices related to compliant computer systems and act as an information resource for delivery teams and the wider business.

Qualifications & Experience

• Minimum 2 years of experience managing equipment/process validation lifecycles and validation documentation development.
• Minimum 2 years 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 Gx P regulations and standards, including 21 CFR Part 820, 21 CFR Part 11, EU Annex 11, and GAMP.
• Experience managing complex validation projects and maintaining validation requirements for computerized systems supporting healthcare products.
• Experience with electronic systems and applications (EDMS, PLM, QMS, LIMS, CMS, ERP).
• Excellent communication and presentation skills, with the ability to convey compliance requirements to stakeholders at all levels.
• Strong written communication skills for development and review of validation and compliance documentation.
• Ability to influence, negotiate, and challenge stakeholders to achieve compliant solutions; adaptable to new situations and changing environments.
• Strong organizational skills with the ability to manage multiple priorities and workstreams.

Education & Travel

• Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related field.
• Travel up to 10% of the time, mostly within Europe.
• Working Conditions

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

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

On-site presence may range from remote to full-time on-site during key project phases, depending on project requirements.

• Additional Information
• Equal opportunities Convatec provides equal employment opportunities for all current employees and applicants.
• Notice to Agency and Search Firm Representatives: Convatec is not accepting unsolicited resumes from agencies or search firms without a valid written agreement.
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