Edison, New Jersey, United States
I am a dedicated Quality Assurance & quality Control professional with 10+ years of experience in the pharmaceutical industry, specializing in quality control operations, stability studies, regulatory compliance & documentation , audit readiness, Change control , Deviation ,CAPA and team leadership.I enjoy mentoring colleagues and fostering collaboration to achieve excellence in QC operations. I have successfully supported multiple international regulatory audits, including USFDA (2015, 2018 & 2024), PMDA Japan (2016, 2024), KFDA Korea & Lachman Audit (2016), ANVISA Brazil (2022), and MHRA UK (2023), ensuring strict adherence to GMP standards and patient safety. Managerial & Leadership Skills: Planned and assigned daily responsibilities to team members, monitored lab operations, and ensured timely achievement of monthly targets. Reviewed analytical documents for accuracy and compliance, prepared corresponding data sheets, and approved finalized reports in accordance with regulatory and quality standards. Stability Studies & Sample Management: Managed receipt of stability intimation sheets, archiving of samples, preparation of protocols and sample distribution sheets, and approvals. Executed sample charging activities in SAP, physically loaded samples into stability chambers, and maintained complete documentation for long-term storage (up to 60 months). Monitored, maintained, troubleshot, and ensured quarterly calibration of all stability chambers. Analytical Expertise: Began career with hands-on analytical testing using UV-Vis, FTIR, SOR, PSD, Karl Fischer, and Auto Titrator. Progressed to become the sole analyst handling XRD for over 6 years, responsible for all XRD-based analysis, documentation, and instrument maintenance — supporting both R&D and commercial batch testing. Proven track record in method execution, GMP compliance, laboratory excellence, and team leadership. Recently, I have also completed a Certificate in Regulatory Affairs, further enhancing my knowledge of global compliance standards. Current Work Authorization: Based in New Jersey, legally authorized to work in the USA (Green Card Holder). I am passionate about maintaining product quality and patient safety and open to connecting with professionals and actively seeking QA,QC & Regulatory opportunities in pharmaceutical/lifesciences industries in New Jersey, USA.