Deviation Investigator

Job Title

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.

Required Competencies

Knowledge, Skills, and Abilities:

• 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 teams.
• Must be action-oriented and customer-focused, building relationships, problem solving, planning and organizing, conflict management, resource allocation, coaching others 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.

Education and Experience:

• B.S. degree required; advanced degree preferred.
• Minimum 5 years Quality Assurance and/or IT experience in a pharmaceutical company