Summary
Overview
Work History
Education
Skills
Accomplishments
Timeline
Sai Charan Madugula

Sai Charan Madugula

Associate Manager
Visakhapatnam,Andhra Pradesh

Summary

Agile and adaptable staff leader with stellar work history, motivational approach and upbeat nature. Skilled at training employees and leveraging organized approaches to handle daily planning, scheduling and customer service requirements. Passionate to carryout basic research, laying a foundation for acquiring & strengthening new skills

Overview

5
5
years of professional experience
9
9
years of post-secondary education
3
3
Languages

Work History

Associate Manager

Pfizer
Vizag, India
10.2021 - Current
  • Investigate Deviations/Incidents that arise in the manufacturing and testing processes using QTS TrackwsieTM, eQMS (Veeva Vault)
  • Perform RCA (Root Cause Analysis) through M1/M2 tools for OOT (Out of Trend), OOS (Out of Specifications)
  • Implementing Corrections, Corrective and Preventive Actions(CAPAs)
  • Perform Effectiveness Checks (EC) post implementation of CAPAs
  • Initiate Change Controls through gQTS (Quality Tracking Systems)
  • Preparation, revision, of SOPs (Standard Operating Procedures), Job aids, Controlled Documents, and Matrix Privilege Documentation
  • Prepare and review Quality Risk Management (QRMs) protocols
  • Review Compendial Changes (USP through PQS, EU, HC and JP)
  • Earned Skill Assessment Badge in Excel
  • Review and approval of Alarm, Annual Product Quality & Environment monitoring reports
  • Ensuring compliance with respect to cGMP in Manufacturing
  • Provide audit compliance responses and implementation of commitment action items
  • Monitoring and Trending of CAPA metrics with an inhosue developed dashboard for entire manufacturing

Associate

Pfizer
Vizag, India
08.2020 - 10.2021
  • Development support of Technical Packages for DP Tech transfer molecules and New Product Introductions (NPIs) to site
  • Preparation of MMRs for Lab Scale, Exhibit and PV Batches
  • Execution of Lab, Scaleup, Exhibit, and PV Batches
  • Administrator of Informa Core Team: Master Data for generation of Automated CPP and CQA, Process Capability charts and,
  • Continued Process Verifications (CPVs) to ensure Zero Defect Transfers
  • Generated trend reports and presentations for senior management.
  • Monitored compliance metrics and performance indicators to identify areas of opportunity.
  • Investigated Market Complain on Odor in a DP MSAT
  • Implemented Informa Statistica for 12 SKUs

Associate

Pfizer
Vizag, India
08.2018 - 08.2020
  • Supervision of Terminal Sterilization activities.
  • Initiation and Handling of Deviations & Events, Protocols. Review of Batch Records
  • Responsible for ensuring compliance & safety of self, my team as per the defined procedures
  • Implemented Data Historian for Terminal Sterilizers
  • Harmonized Flushing Activity from purified water sampling points of Terminal Sterilization Autoclaves
  • simplified Pressure Leak Rate Test reduction, Air Filter replacement frequency, Chamber Spray Washing Cycle frequency, Flushing Time reduction of purified water sampling points in Fedegari superheated water sterilization autoclaves
  • Prepared shift report format, IMEx Tier-0 & Tier-1 Boards with the help of my team leads to streamline handover of shifts.
  • Implemented simultaneous attachment of Batch Attachments to PDOCs which reduced delay in Batch Releases.

Education

Master’s of Pharmaceutical Sciences - Pharmaceutical Technology

Andhra University, Visakhapatnam
08.2016 - 09.2018

8.5 CGPA

Bachelor of Pharmacy - Pharmacy

Jawaharlal Nehru Technological Universit, Kakinada, Visakhapatnam
10.2012 - 07.2016

77%

Secondary School - Biology, Physics, Chemistry (Bi.P.C)

Board of Intermediate Education, Visakhapatnam
04.2009 - 04.2011

92.4%

High School -

Board of Secondary Education, Visakhapatnam
03.2008 - 03.2009

96.3%

Skills

    MS Office Suite

undefined

Accomplishments

  • Supervised team 12 staff members.
  • Certified with six sigma yellow belt
  • Used Microsoft Excel VB editors and Pivots to develop Dashboards
  • Achieved manual interventions by introducing Informa for data collection tasks.
  • Filter Flush and Sample Flush Reduction in Solution Preparation
  • In-Process pH values Harmonization with respect to FP Specifications – Implemented in 3 Months
  • Qualification of Visual Inspection Booths through Bracketed approach
  • Received Pfizer Bold Move Award for
    1) Discontinued Steraffirm Chemical Indicators [80K $ saving/year]
    2) Leak testing recipe Optimization for Plastic family on Wilco
    3) Released 5 Batches by concluding there is no impact due to product carry over [3.2M $ saving]
    4) Vizag Investigations Improvement Journey from 2019 to 2021
    5) Investigating Market Complain on Odor in a DP during MSAT
    6) Implemented Informa- Statistica for 12 SKUs
    7) Implemented Historian inTerminal Sterilization
    8) Planning & achieving 8 product cycles in a shift 3 times

Timeline

Associate Manager - Pfizer
10.2021 - Current
Associate - Pfizer
08.2020 - 10.2021
Associate - Pfizer
08.2018 - 08.2020
Andhra University - Master’s of Pharmaceutical Sciences, Pharmaceutical Technology
08.2016 - 09.2018
Jawaharlal Nehru Technological Universit, Kakinada - Bachelor of Pharmacy, Pharmacy
10.2012 - 07.2016
Board of Intermediate Education - Secondary School, Biology, Physics, Chemistry (Bi.P.C)
04.2009 - 04.2011
Board of Secondary Education - High School,
03.2008 - 03.2009

Similar Profiles

CREATE PROFILE
Sai Charan MadugulaAssociate Manager