Venkateswararao V
Hyderabad
Summary
- Over 9.5 years of professional experience in Biosimilars and Pharmaceutical industry.
- Experience in product release of Pharma and Biotechnology products to European Union and China market.
- Handling of Market Complaints.
- Experienced in handling of QMS and eDMS tools-Trackwise, Agile, SAP, 1QEM, Processpad. Industrial scale upstream manufacturing and QMS experience in both microbial fermentation and mammalian cell culture.
- Academic R&D experience as Junior Research Fellow (JRF-DBT) and Research Associate (RA-DBT).
- Preparation of service transition documents, Handling of Change controls, Incident/deviation Management, OOX.
- Preparation of production protocols, reports and risk assessments.
- Preparation of Quality documents- SOP's, BMR's, MFR. Equipment Validation and Qualification. Digital Transformation-Dashboard preparation with PowerBI, Alteryx, Qliksense
- Global audit experience for commercial Biosimilars-Ukraine, LabPisa, DCGI and GQA in Novartis for Product release.
Overview
13
13
years of professional experience
Work History
Associate Manager
Sandoz Limited (Internal Transfer from Novartis to Sandoz)
05.2023 - Current
- Product Release-Review executed batch documents from warehouse stage to packing stage, including BMR, BPR and all associated documents of the batch and release of batch to global regulated markets.
- Compliance check of the entire batch documents and checking the post submission variations of the product, checking QAA, PSA and other agreements for batch release
- Handling of market complaints.
- Involvement in the process/handling of new service transitions and end to end documentation.
- International exposure communicating with CMO/Supplier, SOM, QAM and QP working at global sites
- Services handled are-BRR- APMA/India exports to Europe, BRR-Barleben, BRR-China and BT&A-EU
- Well versed with all the eDMS tools for generating change control data from TRACKWISE AND AGILE PLM
- Well versed with all the eDMS tools for generating DEVIATIONS, QUALITY EVENTS, OOX data from 1QEM AND TRACKWISE
- Well versed with SAP MODULE P34 to check the VarDB, RegDB for post submission changes and results recording in SAP for batch release activity
- Handling of the Change controls for service Transitions, Handling of Issue logs and Handling of Deviations and associated investigations.
Specialist
Novartis Limited
11.2020 - 04.2023
- Review executed batch documents from warehouse stage to packing stage, including BMR, BPR and all associated documents of the batch and release of batch to global regulated markets
- Compliance check of the entire batch documents and checking the post submission variations of the product, checking QAA, PSA and other agreements for batch release
- International exposure communicating with CMO/Supplier, SOM, QAM and QP working at global sites
- Services handled are-BRR- APMA/India exports to Europe, BRR-Barleben, BRR-China and BT&A-EU
- Involvement in the process/handling of new service transitions
- Well versed with all the eDMS tools for generating change control data from TRACKWISE AND AGILE PLM
- Well versed with all the eDMS tools for generating DEVIATIONS, QUALITY EVENTS, OOX data from 1QEM AND TRACKWISE
- Well versed with SAP MODULE P34 to check the VarDB, RegDB for post submission changes and QA33, BMBC for batch release activity
- Handling of the Change controls for service Transitions, Handling of Issue logs and Handling of Deviations and associated investigations.
Assistant Manager
Dr Reddy Biologicals
01.2017 - 06.2020
- Commercial recombinant protein (Rituximab, Transtuzumab) manufacturing by mammalian cell culture in cGMP plant- upstream operations
- Commercial recombinant protein (GCSF, PEG-GCSF) manufacturing by microbial fermentation in cGMP plant- upstream operations
- Well versed with the operations of all major upstream and lysis operations & equipment including Fermenter, homogeniser, Steam sterilizers, DHS
- SAP operations related to production operations
- Attended Audits-Ukraine, DCGI and internal Global QA
- Production QMS - Preparation of SOP, BMR, MFR
- Change control management, Deviation management and preparation of risk assessments
- Production protocols and reports preparation experience
- Qualification of upstream equipment for GMP operations
- Reviewing of BPR and submission to QA
- Gap analysis and process monitoring Re-Qualification of the equipment or instruments as per planner.
Executive
Biocon Limited
08.2015 - 01.2017
- Commercial manufacturing of rh G-CSF, r-Streptokinase, PEG GCSF by bacterial (E.coli) fermentation
- Isolation and purification of Inclusion Bodies by lysis operation
- Qualification/Requalification of the equipment or instruments as per qualification planner
- Involved in developmental batches till commercialization of biosimilars
- QMS Documentation: Preparation of SOP, BMR, OOS and initiating Change control, Deviations, protocols/reports
- Responsible for preparation of preparation of working cell banks (WCB) in the cGMP facility
- Attended Audits-FDA, LabPisa, DCGI.
Trainee
Biocon Limited
01.2015 - 08.2015
- Microbial recombinant protein (GCSF, PEG-GCSF, Streptokinase, Danae) manufacturing process.
Junior Research Fellow
Kumaraguru College of Technology
07.2013 - 06.2014
- Project title: Characterization and Immobilization of Banana Peel Proteases to incorporate in Wound Dressing Material for Genital Warts
- Protease enzyme isolation and purification from plant source and application for treating wounds.
Research Associate
Integrated Process Development For Bio-ethanol Production From Agricultural Wastes
08.2011 - 12.2011
- Cellulase enzyme production and purification by microbial solid state fermentation.
Education
M.Tech in Industrial Biotechnology -
SASTRA University
B.Tech in Biotechnology -
SRM University
Skills
- Biosimilars operations
- Mammalian cell culture
- Microbial Fermentation
- Product Release
- External Service Operations
- Change control management
- Trackwise, Agile PLM for Change Management
- Deviation/Incident management
- PQ of upstream equipment
- SAP Modules for Results recording
- Dashboard preparation in PowerBI, Excel
- Qliksense
- New service transitions
- Product complaints handling
- Validation and qualification of equipment
- Audits-Internal & external
- Gap analysis and process monitoring
Timeline
Associate Manager
Sandoz Limited (Internal Transfer from Novartis to Sandoz)
05.2023 - Current
Specialist
Novartis Limited
11.2020 - 04.2023
Assistant Manager
Dr Reddy Biologicals
01.2017 - 06.2020
Executive
Biocon Limited
08.2015 - 01.2017
Trainee
Biocon Limited
01.2015 - 08.2015
Junior Research Fellow
Kumaraguru College of Technology
07.2013 - 06.2014
Research Associate
Integrated Process Development For Bio-ethanol Production From Agricultural Wastes
08.2011 - 12.2011
M.Tech in Industrial Biotechnology -
SASTRA University
B.Tech in Biotechnology -
SRM University
Similar Profiles
Harshal SukeHarshal Suke
Specalist at Sandoz, A Novartis DivisionSpecalist at Sandoz, A Novartis Division
SHIVA PARVATHI KANDULASHIVA PARVATHI KANDULA
Specialist (GQSI) at Novartis / SandozSpecialist (GQSI) at Novartis / Sandoz
József SzaboJózsef Szabo
Tactical Planner and S&OP Facilitator at Sandoz, A Novartis DivisionTactical Planner and S&OP Facilitator at Sandoz, A Novartis Division
Sunil SinghSunil Singh
Internship Student at ForageInternship Student at Forage
Venkata Krishna Reddy TallapureddyVenkata Krishna Reddy Tallapureddy
Institutional Sales Manager at DSP Asset Managers Private LimitedInstitutional Sales Manager at DSP Asset Managers Private Limited