Job Description

Summary Of Responsibilities

  • Works with internal teams to progress quality issues in QMS.
  • Tracks timeliness of cases in QMS.
  • Supports teams in creation of CAPAs.
  • Maintains strong working knowledge of QMS.
  • Interacts with QA Lead Manager and above as required for quality issue case progression and client notifications.
  • Supports QA Lead Manager and above in pulling metric data, trending, and tracking of QI.
  • All other duties as needed or assigned.

Qualifications (Minimum Required)

  • A minimum of a bachelor’s degree in Life Sciences preferred (or equivalent Life Science experience).

Experience (Minimum Required)

  • 8 years in regulatory environment (experience in GXP roles).
  • Strong understanding of QMS and CAPA process.
  • Ability to work well within a team environment.
  • Convey key details of quality issues internally.
  • Communicate quality issue summary to clients where applicable.
  • Knowledge of GCPs/GXPs.

Preferred Qualifications Include

  • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Physical Demands/Work Environment

  • Travel may be required.
  • Office-Based (Hybrid), as requested by the line manager.

Learn more about our EEO & Accommodations request here.


Job Details

Role Level: Mid-Level Work Type: Full-Time
Country: India City: Mumbai ,Maharashtra
Company Website: https://fortrea.com Job Function: Quality Assurance & Control
Company Industry/
Sector:
Biotechnology Research

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