Parth Vyas Email & Phone Number

Ahmedabad, Gj, In

Ahmedabad, Gujarat, India

I have 11+ years experience in GCP QA. My highest Qualification is M.Pharm (Clinical Pharmacy). I have recently joined Lambda, Ahmedabad in Clinical Trials QA Late Phase.

Vadodara Area, India

Vadodara Area, India

Job Description:1. Carrying out audit of clinical phase and PKBS phases of clinical study as per protocol, SOPs and applicable regulatory guidelines within the pre-defined timelines.2. Review of Protocols and its related documents as per regulatory requirements.3. Review and verification of qualification, calibration & validation records of equipments/instruments/software.4. Perform System/Facility & Process audits to confirm GCP compliance.5. Ensure… Show more Job Description:1. Carrying out audit of clinical phase and PKBS phases of clinical study as per protocol, SOPs and applicable regulatory guidelines within the pre-defined timelines.2. Review of Protocols and its related documents as per regulatory requirements.3. Review and verification of qualification, calibration & validation records of equipments/instruments/software.4. Perform System/Facility & Process audits to confirm GCP compliance.5. Ensure system up gradation in QA, clinical division as per regulatory requirements.6. Perform audit of vendors and follow-up & support in approval process.7. Preparation and review of SOPs and relevant documents, as applicable.8. Preparation & review of audit report, verification of response and QA statement.9. Review of project specific file prior to archive.10. Provide training on In-house SOPs, regulatory guidance and relevant topics.11. Follow the SOPs and compliance to the quality system.12. Responsible for day to day activities of archival and retrieval.13. Carry out day to day issuance & reconciliation of forms, logbooks and other documents.14. Managing the overall document control activities ready for any time audit/inspection.15. Assist manage the Change control, CAPA, Deviations and prepare Report to management.16. Manage and audit the system related documents at due frequency.17. Assist in monitoring of quality systems of BE facility through System/Facility & Process Audits.18. Any other assignment given by Head QA/designee. Show less

Vadodara

To audit clinical phase, perform in process and retrospective audit in clinical department, perform system and process audit in clinical and all pharmacy related activities, maintain the Audit Schedule Index whenever audit has been performed, report the audit finding in written to the concerned person, provide SOP training to other staff as and when required, Review & Check by the document related to study, During Process screening and study activity inspection, During Process screening and… Show more To audit clinical phase, perform in process and retrospective audit in clinical department, perform system and process audit in clinical and all pharmacy related activities, maintain the Audit Schedule Index whenever audit has been performed, report the audit finding in written to the concerned person, provide SOP training to other staff as and when required, Review & Check by the document related to study, During Process screening and study activity inspection, During Process screening and study activity inspection, Any other Administrative / System related as assigned by the QA Head, To issue the forms and logbooks to the concerned department when required and tomaintain the accountability in the absence of the concerned person. Show less