Sr. Validation Specialist, IT
2 weeks ago
Salary: $110-130k depending on experience
Summary:The Sr. Validation Specialist is responsible for compliance oversight of enterprise CSV projects as part of the IT team. This role is hands-on, highly cross-functional, and works closely with various business stakeholders to ensure GxP compliance. Supports validation of all Manufacturing, R&D, and Quality Systems. Coordinates and/or supports delivery of compliance deliverables such as System Inventory, Quality Impact Assessments, Data Integrity Assessment, Risk Assessments, Gap Analysis, System Remediation, System Change Control and CAPA investigations/resolutions.
***Note***Local candidates onlyThis position will require an on-site presence on occasion/emergencies. However, the position can be remote.
Responsibilities:
- Oversee the execution of qualification/validation activities new software implementations and maintenance of existing systems.
- Author, review and approve qualification/validation documentation (specifications, protocols, risk assessments, reports).
- Perform risk assessments with functional teams to assess system risks and develop mitigation plans
- Update and/or create computer system related policies, procedures, templates, forms, etc.
- Provide input to GxP assessments for 21 CFR Part 11 requirements
- Oversee the execution of qualification/validation activities new software implementations and maintenance of existing systems.
- Author, review and approve qualification/validation documentation (specifications, protocols, risk assessments, reports).
- Perform risk assessments with functional teams to assess system risks and develop mitigation plans
- Update and/or create computer system related policies, procedures, templates, forms, etc.
- Provide input to GxP assessments for 21 CFR Part 11 requirements
- Review and approve computer system change controls, discrepancies, CAPAs
- Review and provide feed to vendor validation documentations (Validation plan, executed protocols, risk assessments)
- Works closely with the QA function to provide expertise in CSV compliance, manage identified issues, and support continuous improvement.
- Support inspection readiness programs and/or directly support regulatory agency inspections. Assist in the coordination of response to any findings as applicable.
- Develop and evaluate quality processes and system standards to ensure compliance with applicable procedures, industry standards and global regulations.
- Minimum of a bachelor's degree in engineering, science or equivalent technical discipline is required.
- Minimum 5+ years of experience working in biotech/pharmaceutical industry in Quality compliance or Computer System Validation role.
- Strong knowledge in CFR 21 Parts 11, GAMP5, electronic record/electronic signature, and data integrity requirements, standards and guidelines.
- Strong background and understanding of FDA regulations.
- Knowledge of Good Clinical practice (GCP), Good pharmacovigilance Practice (GVP), Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Good Laboratory Practices (GLP).
- Experience in authoring/reviewing/approving validation documentation.
- Working knowledge of software development lifecycle (SDLC).
- Experience supporting enterprise software deployments, ERP, DMS, QMS, etc.
- Excellent written and verbal communication skills ability to work with cross-functional teams.
- Experience with vendor audits, quality agreements
- Ability to manage multiple projects
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