List of Responsibilities / Job Functions: |
- Conduct audit of Bioanalytical phase of BA/BE studies, which includes in-process audits, retrospective audits etc. Identify gaps and areas of improvement for compliance to regulatory requirements.
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- Conduct sponsor QA oversight audits of Bioanalytical phase for outsourced BA/BE Studies.
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- Review study documents (e.g. study protocol, Bioanalytical method validation raw data/ reports and Bioanalytical study raw data/ reports etc.) of BA/BE studies in order to ensure compliance with applicable guidelines, regulations and Good Documentation Practice (GDP).
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- Review Bioanalytical study templates, Bioanalytical Method validation templates, SOPs, Annexure, ATP/ Method SOP, instrument qualification (IQ/OQ/PQ/DQ) etc.
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- 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. Harmonize systems and processes with other GCP / GLP sites wherever feasible.
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- Perform other QA audits like System/Facility/Process based audits.
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- Conduct Contract Research Organization (CRO) / Contract Service Provider (CSP) / Material supplier Qualification/ Re-qualification audits.
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- Review Deviation, Incident, Investigation, CAPA and change control etc.
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- Perform trend analysis of deviations, CAPA, change control, incident etc. Support activities of the Quality Review Board (QRB) for continuously improving the quality system.
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- Review response to regulatory queries.
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- Review and approve documents related to Computer System Validation.
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- Prepare audit reports within timely manner; identify any non-compliance/ non-conformance and escalate any critical issue immediately with the senior management (Head, R&D GCP QA/ Head- Site GCP QA and Quality R&D Head), as applicable.
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- 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.
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- Assist Head - R&D GCP QA/ Head - Site GCP QA to coordinate regulatory inspection in collaboration with other R&D stakeholders. Support and implement appropriate CAPA for the identified gaps and resolution of regulatory queries in a time bound manner.
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- Responsible for document control and document management.
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- Impart training or assist in imparting training on applicable guidelines, regulations, SOPs etc.
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- Responsible to ensure GxP Computerized Systems at site are in compliance with the current regulatory standards. (Computerized systems include Firmware based device, embedded systems, Process Control Systems- HMI/IPC, PLC/SCADA, Spreadsheet etc.).
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- Perform the GxP computerized systems assessment and support remediation for ensuring 21 CFR part 11, EU Annex 11 readiness, adequate security and controls.
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- Execute any other work allotted by the reporting authority.
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List of Competencies Required: |
Technical Competencies: |
- Graduate/ Post graduate degree in basic sciences with at least 06-07 years of experience in GCP/ GLP environment of which at least 05 years of experience must be in Quality Assurance
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- Good understanding of international GCP/ GLP regulations and clinical research processes including outsourcing of studies
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- Experience of qualification of CRO/CSP/ Material suppliers
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- Experience of conducting internal and external audits
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- Good knowledge of IT/computer systems
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Behavioral Competencies / Soft Skills: |
- Good problem solving skills
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- Good written and verbal communication skills
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- Ability to work independently
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