Posted 14 hours ago
Quality Review Specialist
Precision Medicine GroupQuality Review Specialist
Requirements
Bachelor's degree, 2 years related experience, eTMF systems experience, FDA & ICH/GCP knowledge, Microsoft Office proficiency
Skills
eTMFICH-GCPFDA
About the role
Responsibilities
- Perform periodic TMF Quality Reviews for assigned projects to ensure audit readiness
- Generate and file TMF documentation related to periodic quality reviews
- Monitor and escalate document processing issues, inconsistencies, or missing documents to the TMF Lead
- Support updates to expected documents and opening of placeholders in the TMF
- Identify potential training needs for team members to encourage consistent TMF maintenance
- Identify and escalate studies at serious risk due to poor quality
Requirements
- Bachelor’s degree or international equivalent
- 2+ years of related experience
- Experience with eTMF systems and vendors
- Working knowledge of FDA and ICH/GCP regulations and guidelines
- Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint)
Preferred Qualifications
- Working knowledge of relevant SOPs and regulatory guidance
- Ability to work independently and within a team environment
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Precision Medicine Group · Bangalore