Qa Auditor
7 days ago
Role & responsibilities
- Conduct external site audit (Late Phase) to ensure compliance with SOPs, Protocol, ICH GCP, and applicable regulatory requirements.
- Review of study documents like study protocol, inform consent, eCRF, Data management plan, study plans, Statistical analysis plan (SAP), clinical study report, etc.
- Audit study database in various clinical data management systems.
- Review and maintain QMS documents like change control, protocol deviation, etc.
- Review study TLFs (Table, listing and figure)
- Review validation documents of software used in clinical studies like clinical data management system (CDMS), eTMF, Clinical trial management system (CTMS), etc.
- Responsible for planning, conducting and reporting of system audit of clinical trial, clinical data management, software development and Bio-stat departments.
- Responsible for planning, conducting, and reporting of vendor audits.
- Review SOPs of various departments like clinical trial, clinical data management, software development, Bio-stat, etc.
Preferred candidate profile
- Minimum 8 years of experience
- Candidate must have experience in the Clinical Trials field
- QA experience preferred
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