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KEM Hospital Pune
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Quality Assurance Officer / Document Officer Clinical Trial

Quality Assurance Officer / Document Officer Clinical Trial

KEM Hospital Pune

2 - 7 years

|

1 - 5 Lacs

Posted:None| Platform:

Apply

Skills Required

qa version control gcp javascript principal investigator clinical research life sciences document management ms office monitoring

Work Mode

Work from Office

Job Type

Full Time

Job Description

The QA/Document Officer will ensure that all study activities are conducted according to SOPs, protocols, and regulatory standards. This role is also responsible for managing documentation, version control, and quality audits.

Key Responsibilities:

Ensure compliance with GCP, SOPs, and study protocols.
Maintain a master file of all essential study documents (ISF, TMF).
Track approvals, amendments, and site communications.
Conduct routine internal audits and quality checks.
Prepare for external audits or monitoring visits.
Ensure timely archival and retrieval of documents.
Support training and version control of SOPs and logs.

Qualifications:

Bachelors degree in Life Sciences, Clinical Research, or related field.
At least 12 years of experience in QA or clinical trial documentation.
Familiarity with ICH-GCP and regulatory requirements.
Strong organizational skills and attention to detail.
Proficient in document management systems and MS Office.

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KEM Hospital Pune

Hospitals and Health Care

Pune Maharashtra

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