Maitri Jariwala

About Maitri Jariwala

I’m a Quality Assurance professional with over 8 years of hands-on experience in…

Experience

1. Qa on Floor Support - Commercial

   Moderna

   Jun 2022 — Present

   Ensure harmonization of QA practice at the Norwood site concerning quality issues and keeping the quality standard policy up to date according to Corporate, ICH, GMP & FDA guidelines. •Perform routine walkthroughs of the manufacturing suites partnering with manufacturing on suite maintenance, Quality best practice implementation and troubleshooting when problems arise. •Provide real time quality oversight and expertise to enable technical success with stringent adherence to a Quality System that respects global regulatory expectations. •Monitor process operations to ensure compliance with specifications. •Ensure facility, equipment and software are properly qualified and validated for GMP use. Ensure Cleaning, Testing and Manufacturing processes are properly validated. •Work closely with the production, quality control and supply chain departments to ensure their practice fully adheres to cGMP. •Ensuring OOS, deviation, change control processes are properly followed, provide QA decisions and approval for these exceptions. Ensuring that investigation determine root cause, impact assessment and appropriate preventative/corrective actions. Ensure timely closure of investigations, and proper escalation to management as per local and global procedures. •Review of manufacturing batch records for product release ensuring all specifications are met and that applicable requirements are completed and acceptable. •Support quality functional groups on as needed basis. •Authors and reviews SOPs, policies to ensure compliance and adherence to regulations/cGMP operations. Utilize knowledge to improve operational efficiency. •Supports audit and inspection as required.

Education

• SHRI P M PATEL INSTITUTE OF PG STUDIES AND RESEARCH IN APPLIED SCIENCE, ANAND

  Master of Science - MS, Biotechnology

  2011 — 2013

• University of Bridgeport

  Master of Engineering - MEng, Biomedical/Medical Engineering

  2015 — 2016