Summary
Overview
Work History
Education
Additional Information
Timeline
Work Availability
Generic

Viswateja Bollapragada

Hyderabad,

Summary

Over 9 years experience in the Contract Research organization and Pharmaceutical/Biotech industries managing QC testing for a wide variety of products from medical devices, small and large molecule and inhaled pharmaceutical products. I have held positions of increasing responsibility at two CRO's, a clinical manufacturing plant and most recently at a contract manufacturing organization as the Quality Control Manager with responsibilities for all aspects of quality control for the manufacture of biopharmaceutical products.

Overview

11
11
years of professional experience

Work History

Quality Control Manager

Promea Therapeutics
Hyderabad
09.2020 - Current
  • Manage the QC department daily activities including: In-process and Lot Release Sample analysis, Stability Studies, and Inspection and testing of Raw Materials
  • Prepared annual budgets with controls to prevent overages.
  • Maximized resource utilization during projects to uphold strict budget targets.
  • Liaised with team members, stakeholders and vendors to coordinate activities, provisioning, environment setup, risk mitigation and follow-up.
  • Manage all client correspondence from project initiation to site audits
  • Support development of novel QC analytical methods working with the analytical development department
  • Manage Quality Control operations to validate and support the manufacturing facility's HVAC system, Gas supply, Purified Water and WFI systems
  • Manage Quality Control equipment validation, calibration and maintenance activities
  • Member of the site Validation Team
  • Write, edit, review, approve and implement site Standard Operation Procedures (SOPs)
  • Write, review, approve and implement product specifications raw material specifications
  • Review and approve Quality Control Laboratory records including environmental monitoring, deviations, corrections, change controls, OOS and lab investigations
  • Support laboratory with 5S implementation and site safety audits
  • Site manager for all outsource testing, responsible for managing contracts, shipments, testing and special projects
  • Manage Quality Control budget and responsible for implementing cost savings within the department

Senior Executive, Quality Control

Recipharm Pharmaservices
Bengaluru
01.2019 - 09.2020


  • Responsible for the Quality Control program for manufacturing for a parenteral & Oral dosages
  • Implemented and managed the Analytical Reference Material program
  • Worked closely with the Quality Teams on site and off site within the JnJ companies to improve the internal Quality Control Systems
  • Managed all Out of Specification (OOS) investigations, Deviations, CAPAs and Change Controls per GMP procedures
  • Managed QMS activities, cGMP and other Regulatory requirements
  • Worked under the compliance of 21 CFR regulatory with out Deviation
  • Well trained in LIMS, SAP Creation of template as per the specification
  • Managed the manufacturing QC testing for the API, Bulk Drug Substance, Drug Product in-process, release and Stability testing program
  • Managed the utility and in-coming raw material testing program
  • Responsible for writing SOP's, Stability protocols, Test Methods, and Stability and utility trending reports
  • Responsible for sample management and all shipments for high levels.
  • Assisted the Quality Assurance group by performing audits for external testing organizations

Sr Executive, Quality Control

Syngene International Pvt Ltd
Bengaluru
08.2015 - 01.2019


  • Responsible for the Quality Control lab at a Contract Research Organization
  • Responsible for the method development, method validation, routine release and stability testing and scheduling for large and small molecule and inhaled pharmaceuticals
  • Implemented, scheduled and performed the following testing: In-process, Finished Testing and Qualification, Calibrations, Stability studies.
  • Implemented, trained, executed Computer system validation (CSV) with in Dept.
  • Wrote and executed equipment IOQ and performance qualifications during start up of the Biologic's laboratory
  • Managed communication with multiple external and internal client projects(Zoetis, PEG-GSF, Insulin, Oncology products(JnJ)) for Analytical testing of Pharmaceuticals
  • Member of the site safety committee

Officer

Medreich Pvt Ltd
Bengaluru
08.2014 - 08.2015
  • Responsible for Monitoring Stability chamber and maintaining records as per Study Protocols
  • Responsible for Developing Stability Protocols and Reports as per Schedule
  • Responsible for Training and Calibration of Analytical instruments (Analytical balance, HPLC, Dissolution, Disintegration,pH, KF)
  • Assist with Complication of QC Documentation metrics
  • Responsible for training all new employees for the company to ICH stability testing and sample management procedures during the initial training orientation

Tr.Chemist

Lee Pharma Limited
Visakhapatnam
01.2013 - 05.2014
  • Responsible for Inward Samples, Testing of samples as per specification
  • Maintained the Good laboratory Practices
  • Handling of Disintegration, Dissolution apparatus including calibration
  • Temperature Monitoring in QC lab on daily schedule
  • Adherence to cGMP & Quality Standards as per regulatory guidelines (ICH)

Education

Master of Pharmacy - Pharmacology

GITAM University
Visakhapatnam
05.2013

Additional Information

  • Excellent interpersonal skills enhanced with professional Leadership Training (Conflict Resolution, Teamwork, Problem Solving and Negotiation Skills)
  • Received site recognition awards for management achievements during two most recent positions
  • Certified in ISO 13845 as Internal Audit, cGMP

Timeline

Quality Control Manager

Promea Therapeutics
09.2020 - Current

Senior Executive, Quality Control

Recipharm Pharmaservices
01.2019 - 09.2020

Sr Executive, Quality Control

Syngene International Pvt Ltd
08.2015 - 01.2019

Officer

Medreich Pvt Ltd
08.2014 - 08.2015

Tr.Chemist

Lee Pharma Limited
01.2013 - 05.2014

Master of Pharmacy - Pharmacology

GITAM University

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
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Viswateja Bollapragada