GxP/SOX Validation Specialist

4 weeks ago

Newark, United States Advanced Software Talent Full time

Our direct client is seeking a GxP/SOX validation specialist for the following opening:

You will handle, IT GxP Systems will work to maintain a stable GxP systems environment to enhance performance, uptime, and compliance. This person will implement IT GxP policies, procedures, and best practices and serve as the organization s IT GxP Systems.

This is an onsite position, with 4 days in the office and 1 day being remote.

Responsibilities
Build and Own IT GxP Compliance program.
Partner with IT and business leadership to select, plan, design, install, and validate GxP Systems in alignment with industry best practices (e.g., GAMP 5), established Quality Directives and SOPs.
Oversee application lifecycles for enterprise GxP IT systems, collaborating with business partners, to ensure effective change control, testing, validation, and communication.
Lead or support deviation/incident investigations related to corporate GxP information systems and manage the implementation of identified Corrective Actions / Preventive Actions (CAPA) resulting from these investigations.
Develop execution plans for IT GxP policies and procedures, including those for architecture, security, backups, disaster recovery, data integrity standards.
Partner with QA to manage systems validation, periodic reviews, and vendor coordination.
Ensure regulatory compliance is aligned with industry best practices and standards.
Maintains adherence of GxP functional and applications administration. This is to ensure IT systems, data and processes meet required service levels and adherence with policies and procedures for compliance.
Manage the deployment, monitoring, maintenance, development, upgrade, and support of all GxP IT systems, including servers, PCs, operating systems, networks, hardware, network, software, and peripherals.
Actively works with internal teams and external vendors and partners on qualification, audit of GxP systems.
Benchmark, analyze, report on, and make recommendations for the improvement and growth of the IT GxP infrastructure and IT GxP systems.Required SkillsSOX Sarbanes certification of Infrastructure required. BS degree in Computer Science, engineering, or STEM concentration
8+ years application management--development, design, admin, configuration, release, validation, governance
Pharma industry experience--GMP, Google Cloud Platform, GLP. CFR Part 11, GAMPS, ICH --some of these
Experience qualifying systems to meet regulatory requirements
Project Management
Experience writing SOP's

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