DURGANAGA MALLESWARARAO THONDAPI
Hyderabad,TG
Summary
Dynamic leader with proven expertise in quality assurance and production management, notably at AuroVaccines Pvt Ltd. Excelled in vendor relationship management and staff training, enhancing operational efficiency and compliance. Demonstrated adaptability and problem-solving skills, achieving significant quality targets and project milestones.
Overview
12
12
years of professional experience
Work History
Assistant Manager - Quality Assurance
AuroVaccines Pvt Ltd
03.2023 - Current
- Lead vendor qualification activities, including new and existing vendor evaluation, conducting vendor audits, and reviewing vendor documents.
- Conduct QA SOP and cGMP trainings for employees.
- Review and approve BMRs, BPRs, SOPs, STPs, Specifications, Protocols, and other quality documents.
- Prepare, review, and send samples to CDL along with Lot Summary Protocol.
- Manage CAPA, Change control, Incidents, PNC, MNC, Exceptions, OOT, and OOS forms.
- Conduct internal audits and ensure compliance with inspection requirements.
- Coordinate with production and QC for batch release processes.
- Oversee IPQA activities and developmental quality assurance.
Senior Officer - Production
Sanofi Healthcare India Pvt Ltd
12.2018 - 02.2023
- Supervised upstream and downstream processes of TT antigen bulk manufacturing.
- Led Upstream team to achieve business and quality targets.
- Conducted aseptic process simulations and process validation batches.
- Managed raw material inventory and ensured cGMP compliance through SAP.
- Sampling and test initiations through LIMS for DS, DP & EM.
- Preparation & review of BMRs, BPRs, SOPs, STPs, Specifications, Protocols, and other quality documents in centralized database Geode+.
- Initiation of Change control, Deviations, CAPA, OOT, and OOS in centralized online QMS system Phenix.
Assistant Manager
Sanctus Bio Pvt Ltd
08.2015 - 12.2018
- Managed hyper immunization of equines against snake venom and tetanus.
- Supervised plasma pheresis and raw material procurement.
- Involved in CPCSEA audits and SOP preparation.
Executive - Production
Biological E
05.2013 - 07.2015
- Actively involved in antisera production, purification, and sterile filtration processes.
- Planned day-to-day activities and maintained cGMP compliance.
- Involved in process validation and equipment qualification.
- Managed cross-functional teams for successful project completion within budgetary constraints and deadlines.
Education
Master of Science - Molecular Biology
University of Skovde
Sweden12-2010
Master of Science - Biotechnology
JJ College of Arts & Science Affiliated To Bharath
Pudukkottai, India04-2005
Bachelor of Science - MLT, MICROBIOLOGY & BIOCHEMISTRY
TSR & TBK DEGREE COLLEGE
Visakhapatnam, India04-2003
Skills
- Time management
- Problem-solving
- Team motivation
- Staff training and development
- Project management abilities
- Adaptability and flexibility
- Verbal and written communication
- Scheduling and planning
- Inventory management
- Vendor relationship management
- Microsoft office expertise
Hobbies
- COOKING
- LISTENING MUSIC
- TRAVELLING
Languages
English
Advanced (C1)
Telugu
Bilingual or Proficient (C2)
Hindi
Intermediate (B1)
Tamil
Beginner (A1)
Timeline
Assistant Manager - Quality Assurance
AuroVaccines Pvt Ltd
03.2023 - Current
Senior Officer - Production
Sanofi Healthcare India Pvt Ltd
12.2018 - 02.2023
Assistant Manager
Sanctus Bio Pvt Ltd
08.2015 - 12.2018
Executive - Production
Biological E
05.2013 - 07.2015
Master of Science - Molecular Biology
University of Skovde
Master of Science - Biotechnology
JJ College of Arts & Science Affiliated To Bharath
Bachelor of Science - MLT, MICROBIOLOGY & BIOCHEMISTRY
TSR & TBK DEGREE COLLEGE
Similar Profiles
Randhir Kumar PrasadRandhir Kumar Prasad
Stacker at Engineering and Allied Services Pvt. Ltd, Lift & Shift India Pvt. Ltd, Roadwings International Pvt. Ltd, Western Carriers India Pvt. Ltd, Tractor India Pvt. Ltd, Transworld Terminal Pvt. LtdStacker at Engineering and Allied Services Pvt. Ltd, Lift & Shift India Pvt. Ltd, Roadwings International Pvt. Ltd, Western Carriers India Pvt. Ltd, Tractor India Pvt. Ltd, Transworld Terminal Pvt. Ltd
SARVESH SHRIYANSARVESH SHRIYAN
Application Consultant /Senior Analyst at Rtv Tech Pvt Ltd (Subsidiary of Rupeeseed Pvt Ltd)Application Consultant /Senior Analyst at Rtv Tech Pvt Ltd (Subsidiary of Rupeeseed Pvt Ltd)
Pranay DubeyPranay Dubey
Director / Authorized Signatory Operations at Shantanu Transnational Life Sciences Pvt. Ltd. & Shree Shyam Balaji Agrovet Pvt. LtdDirector / Authorized Signatory Operations at Shantanu Transnational Life Sciences Pvt. Ltd. & Shree Shyam Balaji Agrovet Pvt. Ltd
Ganesh JosyulaGanesh Josyula
Senior Technical Consultant at InfovitySenior Technical Consultant at Infovity
Pavani GoudPavani Goud
Technology Analyst at DeloitteTechnology Analyst at Deloitte