List of Responsibilities / Job Functions: |
- Conduct audit of Clinical phase of BA/BE studies, which includes in-process audits, retrospective audits etc.
|
- Conduct sponsor QA oversight audits of Clinical phase for outsourced BA/BE Studies (conducted in patients and/or in healthy volunteers).
|
- Review study documents (e.g. study protocol, study plans, IB, ICFs, clinical study raw data/ report etc.) of BA/BE studies in order to ensure compliance with applicable guidelines, regulations and Good Documentation Practice (GDP).
|
- Conduct Contract Research Organization (CRO)/ Contract Service Provider (CSP) / Material supplier Qualification/ Re-qualification audits.
|
- Perform other QA audits like System/Facility/Process based audits.
|
- Create (review and/or coordinate) & implement Quality Assurance (QA) Standard Operating Procedures (SOPs) and global documents (GQSs/ GSOPs). Review and support creation of operational level SOPs in collaboration with relevant stakeholders at R&D.
|
- Review Deviation, Incident, Investigation, CAPA and change control, instrument qualification (IQ/OQ/PQ/DQ) etc.
|
- Review and approve documents related to Computer System Validation.
|
- Prepare audit reports within timely manner; identify any non-compliance/ non-conformance and escalate any critical issue immediately with the senior management (Head, GCP QA/ Head- Site GCP QA and Quality R&D Head), as applicable.
|
- Support creation of appropriate Corrective Action and Prevention Action (CAPA) plan and its execution to meet necessary compliance standards. Verify adequacy of all created & executed CAPAs.
|
- Responsible for document control and document management.
|
- Impart or assist in imparting training on applicable guidelines, regulations, SOPs etc.
|
- Execute any other work allotted by the reporting authority.
|
