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
- To review protocol / SOPs related to bioequivalence
- To conduct in process during method validation and study sample analysis
- To perform retrospective audit (during review raw data chromatogram)
- To review method validation and bioanalytical report
- To review pharmacokinetic and statistics analysis data
- To review clinical study report
Apply: https://careers.syngeneintl.com/job/Bangalore-QA-Auditor-Bioanalytical/1255167300/