GxP Consultant

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Job description

Location: 4000 Centre Green Way Suite 300, Cary, North Carolina 27513 Position Title: GxP Consultant Job Description: Formulate opinions based on broader industry trends, regulatory requirements and help clients maintain quality application in a GxP state. Perform GxP consulting including Good Laboratory Practices, Good Clinical Practices, and Good Manufacturing Practices. Responsible for implementation and computer system validation. Meet with stakeholders to understand capability needs, bottlenecks and business priorities. Review the application requirements and determine the GxP needs. Perform risk assessments and regulatory assessments. Work with development and vendor teams to establish the required compliance requirements on the application. Provide inputs on regulatory and quality questions. Engage with industry experts and leaders to understand industry focus and direction for the future. Understand industry regulations and compliance requirements from regulatory agencies such as the FDA. Develop risk-based validation and regulatory approach to accelerate the drug development and medical device development process. Participate and present in webinars and conferences on regulatory and quality. Review the system development process and prepared risk assessments, regulatory assessments and GxP assessments. Develop regulatory and validation strategy to qualify the application and create the required validation package. Create installation, operational and performance qualification scripts. Establish traceability between the system and regulatory requirements against the qualification scripts. Perform validation testing and create validation summary reports. Create project charter. Define SDLC Methodology (e.g., Waterfall, Agile). Develop change management and risk management strategies. Manage stakeholders and resolve conflicts. Conduct status meetings and status reports. Coordinate with global delivery and validation team from Zifo for validation testing and documentation. Telecommuting one day a week is permitted. Travel and work at client sites as assigned. Multiple positions available. Job Requirements: Requires a Bachelors degree or foreign equivalent in Life Sciences, Biotechnology, Information Systems, Engineering (Any), or a related field plus five (5) years of experience in the job offered or a related role. Alternatively, the employer accepts a Masters degree, or foreign equivalent, in Life Sciences, Biotechnology, Information Systems, Engineering (Any), or a related field plus three (3) years of experience in the job offered or a related role in lieu of a Bachelor degree plus five (5) years of described experience. Requires three (3) years of experience in the following: Research & Development, clinical and manufacturing areas of pharmaceutical industry. Regulatory Consulting, GxP Consulting and Quality area. Required two (2) years of experience in the following: Project management and solution implementation. At least one (1) of the following tools: Drug Development functions, Clinical, or GMP. Waterfall, and Agile. Software Testing and Computer System Validation. Regulatory knowledge on 21 CFR part 11, part 58 (GLP), 210 and 211 (GMP), and 820 (Quality System Regulations). Experience with risk management techniques such as FMEA, 5 WHYs or similar. Office Productivity Tools: MS Project, VISIO, Word, Excel, PowerPoint, or MS SharePoint. At least one (1) of the following: EDC systems, CTMS systems, ELN Platforms, LIMS Systems, Quality and Document Management Systems, or analytical instruments utilized in manufacturing and quality control laboratories. Telecommuting once a week is permitted. Travel and work at client sites as assigned. Qualified applicants please: Email resume, referencing ZT027, including job history, to: .

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