Summary of Responsibilities:
Follow applicable departmental Standard Operating Procedures and Work Instructions.
Complete required training according to required timelines.
Audits System Life Cycle (SLC) activities and documentation.
Plan, conduct, and lead global internal facility, system, and process audits.
Plan, conduct, and lead external audits of vendors and suppliers.
Participates in client and regulatory visits as the subject matter expert in the field of computerized systems and technology compliance.
Author and review controlled documents including but not limited to SOPs and policies.
Advises internal business, IT, and QA partners on systems and technology compliance.
Leads and actively contributes to process and continuous improvement projects.
Ensure Regulatory Compliance and Quality Assurance (RC and QA) responsibilities, as indicated in applicable controlled documents, are followed.
Other duties as assigned by management.
Qualifications (Minimum Required):
A minimum of a bachelor's degree in Life Sciences preferred (or equivalent Life Science experience).
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Experience (Minimum Required):
4 years in regulatory environment (system compliance experience).
Must have a sound understanding of standard computer system development life cycles to provide necessary guidance to both information technology and operational personnel.
Thorough knowledge and understanding of GxP and computerized systems regulations and regulatory guidelines.
Experience applying regulations in at least one GxP discipline and computerized systems standards to the conduct of drug development.
Ability to confidently interact with clients and regulatory personnel.
Ability to conduct effective training.
Ability to effectively negotiate ideas and suggestions.
Strong analytical, organizational, and interpersonal skills.
Preferred Qualifications Include:
A minimum of a bachelor's degree in Life Sciences preferred (or equivalent Life Science experience).
Physical Demands/Work Environment:
Working hours : 2- 11 PM IST (2nd shift hours)
Tasks involve sitting in front of a terminal for many hours during the working day.
Some overtime and weekend work may be required.
Travel Required Regionally up to 5% of the time.
Learn more about our EEO & Accommodations request here.
