Qa Auditor

Cliantha Research

8 - 13 years

8 - 18 Lacs

ahmedabad

Posted:6 days ago| Platform:

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Skills Required

gcp quality assurance clinical trials csv validation and qualification knowledge of regulatory guidelines and compliance requirements qms sponsor handling audit & inspection readiness timeline management auditing

Work Mode

Work from Office

Job Type

Full Time

Job Description

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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