- Core Purpose of the Role :
- To perform study specific in-process audits as per audit plan to ensure that study is conducted in compliance with in-house SOPs, protocol and applicable regulatory guidelines etc.,
- To perform study specific retrospective audits of informed consent document, study files like TMF, case report forms, raw data forms, draft clinical study report and other applicable documents to ensure that study is conducted in compliance with in-house SOPs, protocol and applicable regulatory guidelines etc.,
- To perform database audits in EDC application for applicable studies.
- To prepare and issue audit reports to respective operations team in consultation with Manager/ Department Head and follow-up the implementation of CAPA to ensure timely closure of audit observations.
- To initiate change control and follow-up for the same for timely closure in consultation with Manager/ Department Head.
- To review change control, deviation and other QMS elements taken by operations team and follow-up for its timely closure.
- To review draft documents like Protocol, ICD, CRF etc., before its finalization.
- To assist for system audit as co-auditor and or providing input to Compliance QA team, if required.
- To perform vendor audit as lead/ co-auditor as per vendor audit forecast plan, if required.
- To review qualification and validation documents, if required by Manager/ Department Head.
- To assist and or participate whenever required as per Department Head discretion during system audit, internal and external audits and inspection as part of audit/ inspection readiness.
- To assist in preparation or reviewing the CAPA whenever required during system audit, internal and external audits and inspection.
- To ensure QA records generated are archived on periodic basis.
- To assist Manager/ Department Head whenever required to collate quality systems data for trending the Quality metrics.
- To escalate immediately to Manager/ Department Head in case of any serious non-compliance to protocol and ALCOA+ principles.
- Other Responsibilities:
- To perform or assist any other relevant job with relevant training as and when required by Department Head or Management.
- Role Accountabilities
- To perform In-process audit(s) at various stages, based on the study design & risk
- To perform retrospective audit(s) of clinical study documents against the study protocol, in-house SOP(s) and applicable regulatory guidelines & guidance(s)
Apply: https://careers.syngeneintl.com/job/Bangalore-QA-Auditor-Clinical/1246379300/