28 Jun
CSV - Deviation Investigator
Vacancy expired!
- CAPA
- Deviations/Investigations
- Root Case Analysis
- FDA Regulations
- Incident Investigations
- Computer Systems Validation
- This role will be responsible for the investigation of enterprise-related deviations to determine the root cause and apply 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 the requirement to raise a quality deviation and subsequent investigation.
- 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, Google Cloud Platform, 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 functions.
- Must be able to effectively prepare communications with the interpretation of data analysis and potential problems to management and the group with clarity and a high level of accuracy guidance to other employees in the interpretation of technical issues across interdisciplinary teams.
- Must be action-oriented and customer-focused, building 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 them the 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 the technology platforms as needed for project.
- Experience with electronic Documenting management syste,ms (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.
- S. degree required; advanced degree preferred.
- Minimum 5 years of Quality Assurance and/or IT experience in a pharmaceutical company
Vacancy expired!