Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Swapna Kondapalli

Oak Park,IL

Summary

Compliance Quality Assurance at CVS conducts quality checks on pharmaceutical drug products that comply with GCP. Quality control associate at AbbVie performed quality checks for clinical regulatory documents. Drug Safety Specialist responsible for collecting data on side effects of the drug. Responsible for processing ICSRs that include receipt, data entry, triage, narrative writing, labelling and generating follow up letters for all AE/SAE reports for medicinal products, devices and biologics (clinical study, spontaneous, literature and litigation sources), generate narratives, and follow-up with clinical sites. Healthcare Regulation Specialist experienced in developing healthcare programs designed to improve Long Term Care and Quality Assurance healthcare service delivery at the state and local level. Dentist adept at developing oral hygiene techniques, comprehensive health education programs, creating awareness about the adverse events of the dental issues. Administrative assistant at each career level performed clerical and organizational tasks for multiple supervisors in a timely manner.

Overview

13
13
years of professional experience
1
1
Certification

Work History

Compliance Quality Assurance

CVS
01.2023 - 12.2024
  • Examined pharmaceutical drug products, checking quality and safety by making sure that GMP, GCP, FDA and other requirements are followed
  • Reviewed SOP’s, quality documentation, batch records were examined and approved to guarantee compliance with the company and legal standards
  • Conduct regular compliance assessments and audits
  • Develop and implement policies and procedures to ensure compliance with applicable laws and regulations
  • Maintain a deep understanding of regulatory requirements and keep up-to-date with changes
  • Communicate compliance requirements to stakeholders and ensure they are adhered to work with cross-functional teams to identify and mitigate potential compliance risks
  • Prepare and file medicinal products using Microsoft excel using pivot tables for the regulatory reports and submissions
  • Provide training and support to employees on compliance-related matters
  • Coordinate with external auditors and regulators as needed
  • Assist with the development and maintenance of compliance-related systems and tools

Quality Control Associate

AbbVie
08.2018 - 12.2019
  • Perform quality checks for the clinical regulatory documents by conducting quality control (QC) review utilizing checklists for all applicable documents
  • The documents include clinical study protocol and operations manual, clinical study reports, clinical overview, marketing application, developmental study update reports, benefit risk analysis document, briefing documents etc
  • Support the submission of dossier to health authorities like US-FDA and EMA
  • Checking the final checklists and correcting any errors before the audit review
  • Updating SOP spreadsheet whether training is required for vendors or not
  • Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies
  • Developed and maintained quality assurance procedure documentation
  • Created and revised procedures, checklists and job aids to reduce errors
  • Recorded findings of inspection process, collaborating with quality team to implement corrective actions
  • Analyzed quality and performance data to support operational decision-making
  • Discussion of case studies, deadlines and report concerns to the management
  • Inspected items and compared against standards to meet regulatory requirements
  • Collected and analysed data to measure effectiveness of quality control processes
  • Conducted data review and followed standard practices to find solutions
  • Improved product quality by conducting thorough inspections and implementing corrective actions.

Drug Safety Specialist

Covance
06.2016 - 08.2017
  • Performed medical assessment activities related to ICSR review, and have strong understanding of ICH and GCP guidelines, internal and external guidance documents, SOPs, and case processing/coding conventions
  • Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial
  • Responsible for data entry including coding standards of incoming serious and non-serious adverse events using MedDRA terminology prescribed by global regulatory authorities
  • Triaging incoming cases and assigning appropriate timeline based on seriousness
  • Expertise in writing narrative and drafting brief PV comment for clinical trial and post marketed cases
  • Preparation of case narratives in accordance with CIOMS and particularizing information that is medically relevant to the AE reported
  • Experienced in prioritizing cases and completing cases within given internal timeline
  • Proficient in data entry and excellent knowledge of ARGUS safety database
  • Generated follow up letters for each case
  • Made sure to understand my profile based on its IB (Investigator’s Brochure) and local labelling to provide assessment on event expectedness/ listed Ness
  • Able to assess seriousness of ICSRs in accordance with regulatory definitions and an understanding of the clinical significance of various disease states
  • Able to assess adverse event causality in accordance with regulatory requirements and company’s internal standards
  • Participated in the Quality Control of documents (paper and electronic) submitted to the TMF or eTMF
  • Support the management of TMF documentation issues throughout the lifecycle of an assigned study
  • Prepared and processed all documentation through the Institutional Review Board (IRB – Central and Local), including submissions, continuing reviews, amendments and adverse event reporting
  • Ensured the information presented within the ICSR withstands clinical integrity and is consistent with available source documents
  • Performed case intake and case processing of ESR, SUSAR, PSR submitted to QC based on case deadlines

Public Health Intern | Healthcare Regulation Specialist

ILLINOIS DEPARTMENT OF PUBLIC HEALTH
08.2014 - 12.2015
  • Being Graduate Public Service Intern at Division of Long-Term Care Quality Assurance was responsible for statistical analysis of survey reports to produce nursing home regulatory trends
  • Analyzed and organized data from ASPEN database to note the number of deficiencies in the nursing care homes
  • Implement trend results by developing training materials for review and survey staff, resulting in more consistency in citation reports
  • Worked on power point presentations (Green house project, Residents oral hygiene project, emergency preparedness project, and Infection Control Project) that create awareness and provide necessary education which can be used for lay man understanding, survey staff and long-term care division
  • Worked on living facilities development by entering the audit reports, planning the health services of the residents and reporting qualified services to the department
  • Worked under supervision of the division chief and advocated ongoing nursing facilities issues with the survey staff
  • Created a comprehensive set of guidelines to measure program and policy effectiveness
  • Worked on newsletters on topics assigned by the department
  • Attended conferences, long term care regions phone call meetings, prepared minutes meeting and submitted to the long-term care division department

Dentist and Faculty Member

AUROBINDO DENTAL HOSPITAL
05.2012 - 07.2013
  • Documented patient visits and procedure results
  • Examining patients and interpreting radiographs and diagnostic tests to determine the type and the extent of dental diseases, or dysfunctions
  • Extensive knowledge of equipment used in dental treatments
  • Restoring the form and function of carious, fractured or otherwise defective teeth
  • Performing dental X rays and diagnosing oral problems
  • Performed teeth whitening, teeth cleaning, filling cavities, fixing broken teeth
  • Performed root canal treatment – single sitting, multiple sitting, post and core build ups
  • Performed tooth extraction – nonsurgical extractions, surgical extractions, placing and removing sutures
  • Trained domestic and international dentists every month on the hands-on (Root-canals, Extractions, All type of Fillings, Crowns and Bridges, deep cleaning) dental and community health topics
  • Travelled locally and regionally to conferences, and organized workshops to promote the importance of oral hygiene

Education

Dental Assistant Program -

Triton College
River Grove, IL
01.2022

Administrative Assistant Professional Program -

Computer Systems Institute
Chicago, IL
01.2017

Master of Public Health -

University of Illinois
Springfield, IL
01.2015

Bachelor of Dental Surgery -

Sree Sai Dental College
India
01.2010

Skills

  • Infection Control & Sterilization
  • Dental Impressions
  • Knowledge of Dental Procedures
  • Microsoft Office Suite
  • Outlook
  • Databases : ASPEN, Argus, MedDRA
  • Regulatory Compliance
  • Data Entry
  • Teamwork and collaboration
  • Problem-solving
  • Time management
  • Flexible and adaptable

Certification

  • Basic Life Support Certification (BLS)
  • Certified Dental Assistant (CDA)
  • Graduate Pubic Service Internship (GPSI)
  • Certification in Community Education

Timeline

Compliance Quality Assurance

CVS
01.2023 - 12.2024

Quality Control Associate

AbbVie
08.2018 - 12.2019

Drug Safety Specialist

Covance
06.2016 - 08.2017

Public Health Intern | Healthcare Regulation Specialist

ILLINOIS DEPARTMENT OF PUBLIC HEALTH
08.2014 - 12.2015

Dentist and Faculty Member

AUROBINDO DENTAL HOSPITAL
05.2012 - 07.2013

Administrative Assistant Professional Program -

Computer Systems Institute

Master of Public Health -

University of Illinois

Dental Assistant Program -

Triton College

Bachelor of Dental Surgery -

Sree Sai Dental College

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Swapna Kondapalli