GxP Consultant

Job Requirements: Requires a Bachelors degree or foreign equivalent in Life Sciences, Biotechnology, Information Systems 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 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. Requires 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 one day a week is permitted. This position requires international travel on an as-needed basis. In addition, this position will require travel within the U.S. Specifically, domestic travel will be required about 35% of time, including 25% travel to client sites and 10% travel to other internal offices. 40 hours/week, 9:00am-5:00pm. Qualified applicants please: Email resume, referencing ZT022, including job history, to: Zifo-US