
Senior Investigation Lead
1 semana atrás
Job Overview
The role of Senior Investigation Lead involves conducting comprehensive investigations and root cause analyses to identify the underlying causes of quality events. This position requires a high degree of technical expertise, strong analytical skills, and effective communication abilities.
Key Responsibilities:
- Lead the investigation and root cause analysis for assigned cases to identify and implement corrective actions
- Develop and implement CAPA plans to prevent future occurrences of similar issues
- Collaborate with cross-functional teams to ensure seamless execution of assigned tasks and projects
Investigation and Analysis
This individual will be responsible for analyzing data and identifying trends to inform investigative strategies. They will also develop and maintain complex spreadsheets to track and analyze large datasets.
Qualifications and Experience:
- Bachelor's or Master's degree in a relevant field with 10+ years of experience or equivalent
- Proven track record of success in pharmaceutical industry with experience in data management, operational aspects, GCP Quality, GxP Quality, and/or regulatory
- Regulatory inspection experience and knowledge of clinical trial processes and relationships required
Required Skills:
- Excellent analytical and problem-solving skills
- Strong verbal and written communication skills
- Project management and administrative capabilities
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