The Role
Lead investigations of deviations, non-conformances, and quality events in a regulated manufacturing environment, ensuring compliance and effective CAPAs.
Summary Generated by Built In
QA Specialist / Deviation Investigator to lead investigations of deviations, non conformances, and quality events within a regulated manufacturing environment.
Key Responsibilities:
- Lead end‑to‑end investigations for deviations and quality events.
- Collect and analyze data, conduct interviews, and review technical documentation.
- Apply structured Root Cause Analysis tools (5 Whys, Fishbone, Fault Tree, etc.).
- Develop and manage effective CAPAs addressing true root causes.
- Prepare clear, compliant investigation reports aligned with GMP/GDP requirements.
- Collaborate with Operations, QA, Engineering, and other cross‑functional teams.
- Facilitate and lead problem‑solving and investigation meetings.
Requirements
- Minimum 3–5 years of experience in deviation investigations, QA operations, or quality systems in regulated environments.
- Experience with GMP/GDP environments and documentation.
- Proficiency with CAPA methodologies and root‑cause‑analysis tools.
Skills Required
- Minimum 3-5 years of experience in deviation investigations
- Experience with GMP/GDP environments and documentation
- Proficiency with CAPA methodologies and root-cause-analysis tools
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The Company
What We Do
QRC Group specializes in providing expert consulting services in regulatory compliance, quality management, and risk management for the pharmaceuticals, medical devices, biotechnology, and other regulated industries, delivering comprehensive project management and validation solutions.
