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Validation Deviation Investigator FDA Regulations

Princeton, NJ 08543

Posted: 05/05/2023 Job Number: 23823862

Job Description

Must Have 3-5 yrs of experience with
CAPA, CSV, deviations, FDA Regulations, and Investigations

Required Skills:
  • B.S. Degree required; advanced degree preferred. Minimum 5 years Quality Assurance and/or IT experience in a pharmaceutical company.
  • 2+ years with CAPA, Deviations/Investigations, Root Case Analysis, FDA Regulations, Incident Investigations and Computer Systems Validation.
  • Thorough knowledge of and competence in IT processes, including but not limited to deviations, investigations, CAPA management, SLC, computer system validation, and change management.
  • Must have strong knowledge and experience with cGMP, GCP, GLP Quality, and Compliance.
  • Must have strong authorship and be able to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
  • Must be able to note technical attributes in potential situations or issues and process IT-based solutions across most of the job function.
  • Must be able to effectively prepare communications with interpretation of data analysis and potential problems to management and the group with clarity and a high level of accuracy.
  • Must provide guidance to other employees in the interpretation of technical issues across an interdisciplinary team.
  • Must be action-oriented and customer-focused, building relationships, problem solving, planning, and organizing, conflict management, resource allocation, coaching other and analytical thinking.
  • Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision. Work is self-directed.
  • Confident in making decisions for minor issues.
  • Routinely recognizes Quality issues and solves problems.
  • Proposes solutions for complex issues and works with management to resolve.
  • Follows established procedures and performs work as assigned.
  • Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
  • Ability to interpret results and situations and articulate recommendations for resolution.
  • Able to write and review reports with clarity and brevity.
  • Teamwork and ability to work effectively across functional groups and teams to ensure requirements are met.
  • Excellent verbal and written communication skills.
  • Advanced knowledge of complete MS Office suite. Firm understanding of technology platforms as needed for project.
  • Experience with electronic document management systems (e.G., documentum, Qumas, SharePoint etc.); application development and lifecycle management; and IT service management systems (e.G., ServiceNow, SAP Solution Manager, etc.).
  • Excellent oral and written communication skills in English.

Project Description:
  • This role will be responsible for the investigation of IT Enterprise related deviations to determine root cause and applicable corrective and preventive actions in accordance with FDA, MHRA, and other applicable global health authority regulations.
  • Collaborate with IT and Quality resources to collect relevant information for deviation assessment and facilitate meetings with investigation teams.
  • Manage deviation records and monitor completion of corrective actions within a Quality Management System.
  • Investigate IT incidents with technical and business stakeholders to define if there is potential GxP impact and requirement to raise a quality deviation and subsequent investigation.

This 10+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Loren: loren@alphaconsulting.Com


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Loren Graham

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