Summary
Overview
Work History
Education
Skills
Timeline
Generic

Maurya Seeta

Cleveland,OH

Summary

- Pharmacist from India with proven technical knowledge in Regulatory Affairs, Quality Assurance, Documentation and Compliance.
-3.5 years of experience in Clinical Research/Regulatory affairs field and 2 years of experience in Pharmaceutical industry - Packaging & Inspection

Overview

6
6
years of professional experience

Work History

Compliance Quality Assurance Specialist-Training

Xellia Pharmaceuticals
Bedford, OH
05.2022 - Current
  • Provide quality oversight to all Doc Control, Change Control, Deviation Management, APR’s, Auditing, Laboratory, Complaints, Reprocess, Recalls and Supplier Qualification to ensure product quality and SOP/GMP compliance at Cleveland Manufacturing Facility
  • Function as site LMS administrator, Support design and implementation of site-wide or global training material.

Non-Sterile Operations Process Specialist

Xellia Pharmaceuticals
Bedford, OH
08.2021 - 04.2022
  • Support Doc Control, Change Control, Deviation Management, Auditing and Supplier Qualification
  • Lead investigations and root cause analysis. Participate in investigations and execute appropriate approved corrective / preventative actions for Inspection and Packaging related processes

Production Operations Coordinator

Xellia Pharmaceuticals
Bedford, OH
08.2020 - 07.2021
  • Author, Approve or Authorize SOP’s and/or qualification/validation documents as assigned
  • Assemble batch relevant documentation to support the production process

Senior Clinical QA/RA

WorldCare Clinical LLC
Boston, MA
01.2019 - 07.2020
  • Participate in establishment of baseline parameters and edit check specifications, and in the development of subject tracking systems for clinical trials.
  • Reviewing the case report forms, tracking and processing data from sites according to the Study protocols and performing verification, quality control checks of data received from investigator sites and Trial sponsors

Clinical QA/RA Associate

WorldCare Clinical LLC
Boston, MA
01.2017 - 12.2018
  • Documenting and updating SOP’s, Work Instructions, Forms and Templates, supporting Quality and Regulatory activities
  • Plan and perform periodical quality checks of (e)Trial Master Files & the Paper TMF Files
  • Provide support for the Learning Management system processes and Document Management System processes .

Quality Control Intern

Gland Pharma Limited
Hyderabad, India
07.2014 - 12.2014
  • Analyzing information of given samples- physical, chemical and microbial measurements and observe their quality testing
  • Preparation of technical files, risk assessments and quality audits, verification and validation of analytical reports

Education

Master of Science - Regulatory Affairs For Drugs,Biologics And Devices

Northeastern University
Boston, MA
12.2017

Bachelor of Science - Pharmacy

Osmania University
Hyderabad, India
07.2015

Skills

  • Knowledge of GxP’s such as GMP, GCP, GLP, ICH guidelines; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; 45 CFR 46; 21CFR 210 and 211,TMF; Regulations for Clinical trials, Adverse Event Reporting
  • Safety tools: MedDRA, Pubmed, PharmaReady, JIRA, Master control, Trackwise, IntelePACS, Sante DICOM editor

Timeline

Compliance Quality Assurance Specialist-Training

Xellia Pharmaceuticals
05.2022 - Current

Non-Sterile Operations Process Specialist

Xellia Pharmaceuticals
08.2021 - 04.2022

Production Operations Coordinator

Xellia Pharmaceuticals
08.2020 - 07.2021

Senior Clinical QA/RA

WorldCare Clinical LLC
01.2019 - 07.2020

Clinical QA/RA Associate

WorldCare Clinical LLC
01.2017 - 12.2018

Quality Control Intern

Gland Pharma Limited
07.2014 - 12.2014

Master of Science - Regulatory Affairs For Drugs,Biologics And Devices

Northeastern University

Bachelor of Science - Pharmacy

Osmania University

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