Summary
Overview
Work History
Education
Skills
Timeline
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Sanjana Bappal

Bangalore

Summary

Quality Specialist III at Teva Pharmaceuticals with extensive experience in handling complaints for the US market, including coordination with regulatory agencies and adherence to Good Manufacturing Practices (GMPs). Previously served a Quality Assurance Officer at Medreich Led, managing QAMS-related activities, Training and riak cascasments. Career goal:- To put knowledge and skills to practical use in the best possible way and to strive for excellence and reach the pinnacle of success in the field of pharmacy while broadening horizon of expertise and be a valued asect to the organization.

Overview

6
6
years of professional experience

Work History

Quality Specialist III

Teva Pharmaceuticals
Bengaluru
08.2023 - Current
  • Was responsible for receiving, categorizing, trending and logging complaints for the US market
  • Coordinating for return of samples for product quality-related complaints from customers (patients, doctors, pharmacists, HCPs or any other customers who use or handle Teva products).
  • Handling of complaints related to biological products, autoinjectors, combination products, creams and ophthalmic solutions.
  • Handling critical complaints and determining whether the complaint could potentially require a field alert, rapid alert notification or both.
  • Performed let level trending for various products.
  • Handling of Root cause analysis and CAPAS.
  • Performing and review of gap scaments for SOPs
  • Logged 3000+ reports in Trackwise within stipulated timeline.
  • Resolved issues effectively and built customer rapport, which lead to enhanced customer satisfaction.
  • Quickly learned new skills and applied them to daily tasks, improving efficiency and productivity

Quality Assurance Officer

Medreich Limited Unit-7 (Meiji Group)
Bangalore
07.2019 - 04.2023
  • Significance experience in pharma GMP & GDP environment Awareness of quality ayatema and standard procedures
  • Handling of QM5 (Market complaints, Change controls, CAPA and Risk casessment).
  • Having knowledge about 21 CFR part-11.
  • Issuance and Document control, Storage and archiving of documents and maintenance of documents and records as required.
  • Conducted evaluations to identify weak areas and identify problematic issues while promoting corrective methods.
  • Preparation and review of departmental SOP's in co-ordination with respective departments
  • To co-ordinate for conducting training programs through LMS.
  • Responsible to co-ordinate with all cross functional departments and collect required documents within stipulated timeline.
  • Active participants in Regulatory affairs External and internal) PMDA TGA, ANVIA and customer audits Mylan, Novartis, GSK and Senofi).
  • Responsible for investigating incidents (includes microbial excursion) and timely closure in co-ordination with cross functional teams (CFTS).
  • Total 400+ investigation reports were prepared and shared to customer within timeline.
  • CAPA assigned for the identified root cause were implemented within target timeline.
  • Involving extensively in streamlining and accelerating investigation process

Education

Mater's in Pharmacology -

PES College of Pharmacy
Bangalore
05.2019

Bachelor of Pharmacy -

KLE University
Hubli
04.2017

High school -

Swami Vivekananda high school
Puttur
04.2011

Skills

  • Market complaints
  • Change control
  • Deviation
  • CAPA
  • SOP development
  • Trackwise

Timeline

Quality Specialist III

Teva Pharmaceuticals
08.2023 - Current

Quality Assurance Officer

Medreich Limited Unit-7 (Meiji Group)
07.2019 - 04.2023

Mater's in Pharmacology -

PES College of Pharmacy

Bachelor of Pharmacy -

KLE University

High school -

Swami Vivekananda high school

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Sanjana Bappal