Summary
Overview
Work History
Education
Skills
Websites
Accomplishments
Languages
Application Knowledge
Association Membership
Audits Faced
Personal Information
Disclaimer
Timeline
Generic

Appala Naidu Kundrapu

Chantilly,VA

Summary

Knowledge on various elements within Quality Assurance with 08 years of core background in Pharmaceutical Industry.

Maintain excellent collaboration and communication with inter-departmental people for timely closure of outstanding Quality events. Prioritization of activities, multitasking and organizational skills. Committed to paying impeccable attention to reviews and auditing procedures.

Overview

8
8
years of professional experience

Work History

QA Associate

Granules Pharmaceutical Inc.
07.2023 - Current
  • Review of In-house Manufacturing Batch Records and third party batch records and responsible for release of products.
  • Handling of Market Product Complaints- Receipt, Initiation, investigation of complaints and closure.
  • Oversee the implementation of the Quality Management System, including ongoing development and maintenance of QA systems and procedures.
  • Performing internal inspections as per schedule and performing external audits. Preparation of audit responses for the identified observations and tracking for the audit reports for closure.
  • Evaluation of quality deficiencies, incidents and initiating the follow-up activities in the GMP departments.
  • Implementation of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) and its procedures
  • Actively participating in Environmental monitoring activities in GMP area and review of monitoring results and documenting the closure reports.
  • Involving in Qualification of Equipments (Purified Water System) and review of executed protocol for final closure.

Senior Executive

Teyro Labs Pvt Ltd (Formerly known as Accord Life Spec)
03.2021 - 03.2023
  • To ensure completion of all QMS documents such as Change Controls, Deviations, CAPA etc.., within the targeted completion timelines
  • To review and handle change control, Deviation, and CAPA with respect to Quality under GMP aspects
  • To prepare investigation reports corresponding to the deviations and ensure CAPA initiation and follow-up actions to close for the same
  • To review all the QMS documents and check for the compliance of the activities completion for the same
  • To prepare quality presentation for senior management meetings on Quality Systems on monthly basis
  • Responsible for Induction and departmental training of new recruits and preparing on-job curriculums.
  • Preparing for Internal audits in accordance with schedule and coordinating with other departments and preparing audit compliance report with respect to the observations and submitting the audit response.
  • Aid in preparation of regulatory Audits and making the compliance for the same.

Reviewer-I

Apotex Research Pvt. Ltd
09.2015 - 02.2021
  • Handling of Quality Management systems and conducting CCB meeting for Change control through QMS track wise application.
  • Monitoring of Dispensing of Raw Material and Packing Material and Sampling of different stages of Raw material and packing material activity for issuance.
  • Giving line clearance, In-process checks and monitoring of QA related material
  • To ensure the control over the issuance of documents like BMR, BPR, Logbooks, GMP documents by handling the online Document Management System.
  • Prepare and support Regulatory Inspections and Sponsor Audits in collaboration with QA Management
  • Preparation, Review and Approval of Standard Operating Procedures (SOP's), Monthly Reports, Maintenance and Updating of Master lists of SOP's, FORMATS and its records
  • Exposure to regulatory audits like USFDA, MHRA, TGA, Health Canada, etc..

Education

M. Pharmacy -

K.C Reddy Institute of Pharmaceutical Sciences
12.2013

B. Pharmacy -

Koringa College of Pharmacy
04.2011

INTERMEDIATE -

Sri Sai Co-operative Jr.college
03.2007

10th Std./ SSC -

Sri Prakash Vidhya Niketan
03.2005

Skills

  • Quality Management Systems
  • Document Control
  • Regulatory Compliance
  • Internal Inspection and external Audits
  • Audit Coordination and Audit Reporting
  • Complaint Investigation and Root Cause Analysis
  • Vendor Qualification
  • Market Product quality monitoring
  • Cross-functional Collaboration
  • Work Planning and Prioritization

Accomplishments

  • Selected as Subject Matter Expert (SME) for explanation of QMS systems during USFDA inspection in Mar-2023
  • Successfully achieved in closure of USFDA audit observation (Purified Water deviation) by effectively working on investigation and closed within one day.
  • Collaborated with team of 3 members in effectively collecting, revising and completing all documentation on project Transition within 40 business days.
  • Through involvement in Regulatory audit and awarded as "Best Runner" during the inspection.

Languages

English
Telugu
Hindi
Kannada
Tamil

Application Knowledge

QMS Track-wise, SAP Application, MS-Office, Excel and Internet Applications

Association Membership

A registered member of Indian Pharmacy Council (IPC)

Audits Faced

  • USFDA - USA
  • MHRA - UK
  • TGA - AUSTRALIA
  • HEALTH CANADA - CANADA

Personal Information

  • Date of Birth: 12/07/89
  • Gender: Male
  • Nationality: Indian
  • Marital Status: Married

Disclaimer

I declare that the information given above is true to the best of my knowledge and belief.

Timeline

QA Associate

Granules Pharmaceutical Inc.
07.2023 - Current

Senior Executive

Teyro Labs Pvt Ltd (Formerly known as Accord Life Spec)
03.2021 - 03.2023

Reviewer-I

Apotex Research Pvt. Ltd
09.2015 - 02.2021

M. Pharmacy -

K.C Reddy Institute of Pharmaceutical Sciences

B. Pharmacy -

Koringa College of Pharmacy

INTERMEDIATE -

Sri Sai Co-operative Jr.college

10th Std./ SSC -

Sri Prakash Vidhya Niketan

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Appala Naidu Kundrapu