QA Computer System Validation Consultant

Innova Solutions has an immediate need for an

• (21 CFR Part 11, 211, 820, and Annex 11), experience writing VMP, VSR, and IQ/OQ/PQ protocols, and SDLC methodologies (GAMP).

• Writes, executes, and reviews validation protocols, generates validation reports, and performs corrective actions for deviations to provide subject matter expertise for SCS in validation matters.
• Reviews policies, procedures, and regulations with internal/external clients to determine specialized requirements and ensure compliance.
• Coordinates document and data control (e.g., numbering, version control, controlled copies, etc.) to ensure documentation and data are maintained in an orderly manner and meet quality standards.
• Leads validation personnel or projects, when assigned.
• Records information and observations from internal audits to support the preparation and distribution of internal audit reports.
• Establishes and maintains quality policies and programs within the IT area to ensure proper document and data control methods are utilized.
• Interfaces with client QA departments and attends sales presentations and business reviews to support the coordination of client activities.
• Interacts with internal auditors to discuss audit plans and findings.
• Ensures continued learning of new/existing regulatory requirements by the various regulatory bodies governing our healthcare industries.
• Participates in consultations with Corporate Legal to determine compliance implications of pending business.
• Ensures consistent and timely completion of compliance-base tasks as assigned including but not limited to NCs, CAPAs, Audit findings and Document Changes/Management
• Follows up with clients after audits to identify issues and mutually acceptable solutions.

• Possesses knowledge of Supply Chain logistics
• Experience in the Healthcare industry
• Minimum 3 years' computer system validation in a pharmaceutical/medical devices environment, including thorough knowledge of regulations and guidelines (21 CFR Part 11, 211, 820, and Annex 11), experience writing VMP, VSR, and IQ/OQ/PQ protocols, and SDLC methodologies (GAMP).