28 Jun
CSV - Deviation Investigator
New Jersey, Princeton , 08540 Princeton USA

Vacancy expired!

Title: CSV - Deviation Investigator

Location: Princeton, NJ 08543/ onsite from day 1

Duration: 6 Months (possible extension)

Note: Vaccination is mandatory

The EM needs 3+ years of experience in the following:
  • CAPA
  • Deviations/Investigations
  • Root Case Analysis
  • FDA Regulations
  • Incident Investigations
  • Computer Systems Validation

Job Description:
  • 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.

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, 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.

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

Vacancy expired!


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