Experience

CMIC, Inc.

• United States
• Biotechnology Research
• 1 - 100 Employee

• Quality Assurance associates

  • Mar 2023 - Present



Labcorp

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Specimen Processor

  • Dec 2022 - Mar 2023



Synchron Research services Pvt.Ltd.

• Ahmedabad, Gujarat

• Manager

  • Aug 2007 - Aug 2021

  As research regulatory compliance analytical auditor and team leader, ensured project specific bio analytical process and data audits are conducted as per the QA SOPs, GLP, regulatory guidance and as per QA programs in order to fulfill the scheduled time lines. Conducted QA review of the bio analytical part of the study protocols as per internal SOPs and various regulatory agencies requirements such as US FDA, EMA, MHRA (UK), WHO and others. Conducted in-process audits of various Bio analytical Phases like Calibration, Curve CC/QC spiking solution preparation, Matrix Spiking, Subject Sample Batch Processing, etc. Reviewed and audited the analytical method SOPs, method development data, method validation raw data , reports ,study specific bio analytical raw data, bio analytical report to ensure data intergrity. Conducted periodic internal system audits in different process ,system audits of current trials and IQ/OQ/PQ instrumentation areas and documentation in bio analytical, preparation of audit reports, follow-up and close-out audits observations. Assisted QA HOD in generation and analysis of QA metrics for audit observations and presentation of noncompliance trends at the management review meetings to establish efficient and effective strategies for the improvement of quality, compliance and performance. Assessed overall study compliance for GLP, 21 CFR & applicable regulatory requirement and prepare QA Compliance statements for study reports. Assisted and conducted vendor audit/assessment/qualification Conducted internal system audit to assess compliance for regulatory inspection/sponsor audit preparedness as required. Assisted /manage with QAHOD in regulatory inspection preparedness and inspection management of documents and help the bioanalytical inspectors navigate the study data and documentations. Review the bio analytical research process and instrumentation SOPs to ensure compliance with internal SOPs, GLP, GCP and other applicable regulatory requirements