- Conduct CAPA investigations to identify root causes of deviations, non-conformities, and out-of-specification results.
- Develop and implement corrective actions to prevent recurrence of issues in accordance with cGMP regulations.
- Collaborate with cross-functional teams to resolve quality-related issues and ensure compliance with QMS requirements.
- Review and approve CAPAs before implementation to ensure they meet regulatory requirements.
Job Requirements :
- 3-8 years of experience in a pharmaceutical or life sciences industry in a similar role.
- Strong understanding of GMP/cGMP regulations and their application in a manufacturing setting.
- Experience with investigation techniques such as FMEA, Fishbones, etc.