Ravi Kumar dondapati
East Godavari
Summary
Experienced professional seeking a challenging position in the biotechnology and pharmaceutical fields. Skilled in executing qualifications for Fedegari Superheated Water Sterilization Autoclaves operated by THEMA-4 software at Pfizer Healthcare India Private Limited. Involved in initial qualification activities of autoclaves, including Site Acceptance Test, Installation Qualification, Operational Qualification, and Performance Qualification. Possess extensive knowledge of Terminal Sterilization Process and experience in manpower adjustment and preparing shift schedules according to production schedules. Proficient in executing activities such as Electronic Batch Record through SAP and using electronic log books like E-Log, P-Log, PDOCS, and G Lims at Pfizer Health care India Pvt Ltd . Eager to contribute to dynamic and systematic growth in the industry.
Overview
18
18
years of professional experience
Work History
Team Leader
Pfizer Healthcare India Pvt Limited
Vishakhapatnam
01.2012 - 03.2025
- Execution of qualifications for Fedegari Superheated Water Sterilization Autoclaves operated by THEMA-4 SOFTWARE
- Involved the qualifications for IMA Vial washing, FILLING & CAPPING machines
- Involved in the initial qualification activities of autoclaves (Site Acceptance Test, Installation Qualification, Operational Qualification & Performance qualification)
- Having considerable work knowledge on Terminal Sterilization Process
- Execution of PRQ protocols of super heated water sterilization autoclaves
- Co-ordination with CFT' for compilation and certification of protocols
- Preparation and approvals of deviations
- Co-ordination with Quality department for closing of regular batch exceptions
- Co-ordination with batch release team and support release the batches ontime as per plan
- Preparation of shift schedule and batch planning activities as per production plan
- Managing and utilisation of man power as per priorities
- Manpower management
- Planning & Execution of activities as per priority
- Ensuring for compliance of quality systems in production area
- Six Sigma lean belt certified
Officer
Indian Immunologicals Ltd
Hyderabad
11.2006 - 01.2012
- Expertise in Filling and sealing of vaccines like Hepatitis-B, TT, DT, DPT and measles
- Actively involved in aseptic process simulation for formulation and filling
- Monitoring area and equipment as per cGMP standards
- Considerable experience in the operation of the equipments like Autoclave, DHS, Tunnel sterilizer, Rubber stoppers washing machine, automatic filling, bunging, and sealing machine
- Involved in the validation activity of Autoclave, DHS and Tunnel sterilizer, automatic filling, bunging & sealing machine
- Experience in Operation of Integrity testing machine (Palltronic) for checking the hydrophilic and hydrophobic filter integrity
- Individual handling experience on 200/1000 Liters Blending vessels, mobile vessels, ballast vessel, cartridge filtration system, transfer lines and other accessories through CIP/SIP System
- Experience in Trouble shooting techniques for Autoclave, filling machine capacity of 120/200 vials/min
- Preparation and review of SOP's at formulation, filling and finished product stages as per cGMP standards
- Preparation and review of BMR for Filling and Finish product stages
- Coordinating with QA department for area/equipment validations
Education
Master of Science - Microbiology
Acharya Nagarjuna University
Guntur04-2010
Bachelor's Degree - Botany, Zoology and chemistry
Andhra University
04.2005
Intermediate (+2) -
Board of Intermediate Education
Andhra Pradesh04.2002
SSC -
Board of Secondary Education
Andhra Pradesh04.2000
Skills
- Manpower management
- Quick learner
- Good Communication skills
- Good in documentation as per current regulations
Personal Information
- Date of Birth: 01/08/85
- Marital Status: single
Father's Name
Mohan Rao
Total Years Of Experience
18.2 Years
Languages
Telugu
First Language
English
Upper Intermediate
B2
Hindi
Elementary
A2
Audits involved:
- US FDA
- MSQA
- WHO
DECLARATION:
I here by declare that the above given information is correct to best of my knowledge and belief.
Signature & Date
Timeline
Team Leader
Pfizer Healthcare India Pvt Limited
01.2012 - 03.2025
Officer
Indian Immunologicals Ltd
11.2006 - 01.2012
Master of Science - Microbiology
Acharya Nagarjuna University
Bachelor's Degree - Botany, Zoology and chemistry
Andhra University
Intermediate (+2) -
Board of Intermediate Education
SSC -
Board of Secondary Education