Senior Compliance Advisor
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Job Description
CSV Senior Compliance Advisor ensuring compliance and validation for GxP computerized systems in a leading medical products company focused on chronic condition management.
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.
- 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.
Requirements:
- Bachelor’s degree in computer science, engineering life science or related field.
- 5 years experience with CSV validation lifecycle management and validation documentation development.
- Minimum 2 years experience with CSV, process validation, QA or compliance functions in pharmaceutical or Medical Device industry.
- Excellent understanding and experience with industry regulations, standards, and guidelines, e.g., GxP, validation, 21 CFR Part 11, etc.
- Strong understanding of GXP Regulations 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.
Benefits:
- Health insurance
- Retirement plans
- Paid time off
- Professional development opportunities
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