Systems Technology Compliance Senior Specialist

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.

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