QA Auditor -Bioanalytical - Clinical Research Jobs

Core Purpose of the Role:

Quality Management System (QMS): Responsible for the QMS of departments related to Bioanalytical Research Laboratory, Data Management and Biostatistics and other support departments of Syngene Clinical Development.
Standard Operating Procedures’ (SOPs): Preparation and revision of SOPs, review of SOPs from relevant departments, any other responsibilities as indicated in relevant SOPs.
Change Control: Initiate relevant change controls, review of change control taken by the departments, follow up of the same for closure.
Record control –Control and maintain records in the QA department.
Qualification and validation: Review of qualification and validation documents.
Audit Management: Plan (including preparation of relevant audit related documents, review of documents) and perform relevant audits: study-based audits (including site audits), quality system audits, process audits. Prepare audit reports, review audit reports generated by peers, review corrective and preventive action plan generated and follow-up on the closure of the same. Alternatively, follow-up audits can be done.
Authorized to conduct vendor audits.
Review of relevant documents such as protocol, testing procedures, study plan, clinical study report; and so on.
Share best practices and ideas with fellow QA personnel.

Role Accountabilities

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