GxP Consultant Job

Company: Zifo Technologies, Inc.

Position Title: GxP Consultant

Location: 4000 Centregreen Way, Suite 300, Cary, NC 27513

Position Responsibilities: Meet with Stakeholders to understand Capability needs, Bottlenecks and Business Priorities. Review the application requirements and determine the GxP needs (GLP/GCP/GMP). Work with customer Quality, Regulatory, Compliance team to 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 & quality questions. Engage with Industry Experts and Leaders to understand Industry Focus and direction for the future. Understand Industry Regulations and Compliance requirements (21 CFR Part 11) from Regulatory agencies such as FDA. Develop risk-based validation and regulatory approach to accelerate the drug development and medical device development process. Participate / Present in Webinars / Conferences on Regulatory and Quality. Review the system development process and prepare 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 & 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 & 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.

Position Requirements: Bachelor’s 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 position. Experience must include: three (3) years of demonstrated domain knowledge in R&D, clinical & manufacturing areas of pharmaceutical industry, regulatory consulting, GxP Consulting & Quality area; two (2) years of experience in project management & solution implementation; demonstrable knowledge in one (1) of the following: Drug Development functions, Clinical, or GMP; demonstrable knowledge of: Software Development Process, Waterfall, Agile, Testing & Computer Software Validation, regulatory knowledge on 21 CFR 11 & 58 (GLP) / 210 & 211 (GMP) / 820 (Quality System Regulations), risk management techniques, & MS Office Tools; demonstrable knowledge in one (1) of the following: ELN Platforms, LIMS Systems, Quality and Document Management Systems, or Analytical Instruments utilized in manufacturing & quality control laboratories. Alternatively, will accept Master’s degree PLUS three (3) years of described experience. Any suitable combination of education, training, or experience is acceptable. Multiple positions available. May telecommute from any location within the U.S. Travel to unanticipated client locations, throughout the U.S., approximately 20%, as required. Supervise four (4) subordinate employees.

To apply, please email resume to [email protected]. Reference job code 60619.0035