AnaCipher Hiring Executive IQC - B.Pharm, M.Pharm Apply

AnaCipher Clinical Research Organization, a division of Indoco Remedies Ltd. is a Contract Research Organization specialized in bioequivalence and analytical studies. The state-of-the-art facility is spread over an area of 40,000 sq. ft. at Hyderabad, India, with capabilities to conduct bioavailability and bioequivalence studies, bioanalytical method development and validation, sample processing and analysis, statistical analysis and reporting.

Post : Executive IQC

Qualification : B.Pharmacy / M.Pharmacy

Experience : 1 -2 years

Department : Clinical

Job Description
• Compliance of essential documents before/during/after study.
• Review the central study file, regulatory dossier and final study report.
• Review of study protocol, study specific CRFs, ICDs prior to the initiation of the study.
• Monitor and review clinical study activities, documents, logbooks online to ensure compliance to SOPs and Good Clinical Practices and other regulatory requirements.
• Review reports generated during the study period against the raw data with source data.
• Review the project specific raw data for accuracy, completeness and internal consistency and compliance to SOPs, protocol, ICDs and CRFs.
• Verify whether the corrective actions have been implemented and preventive measures have been taken to the findings of the review.
• Update the summary of the projects compliance status from time to time.
• Perform periodic review(s) of the facility, logbook entries, temperature/humidity records, and report findings of the same.
• Verify the calibration, maintenance of clinical equipments and ICU equipments to ensure compliance to SOPs and Good Clinical Practices.
• Maintain the training records and provide information for updating CV of all Study Personnel in the Clinical Department.