ASHOK KONAKALA
CQV & CSV
Summary
To lead and play a significant role in execution of CQV projects of Biologics & Pharma Manufacturing facilities using my thorough knowledge in Process design, Commissioning and Qualification of Mammalian, Microbial, API, Injectables & OSD facilities for the development of self and the organization.
Overview
10
10
years of professional experience
Work History
Assistant Manager | CQV & CSV
Syngene International Limited
03.2021 - 06.2025
- Led CQV and CSV document Preparation, Review and Execution for biologics manufacturing plants, ensuring successful system and facility release in Bangalore.
- Managed Periodic Validation and Re-qualification of critical equipment, upholding continuous compliance.
- Collaborated with cross-functional teams to streamline workflow processes, resulting in reduced turnaround times for project deliverables.
- Provided comprehensive Audit support, identifying gaps, conducting impact assessments, and proposing/initiating CAPA and Change Controls.
- Facilitated daily interaction and coordination with cross-functional teams to ensure timely completion of all CQV & CSV activities.
Assistant Manager | Quality Assurance – Validation
DD Enterprises
09.2020 - 02.2021
- Reviewed system design documents, including P&ID, General Arrangement (GA), 3D models, and Functional Design Specifications (FDS).
- Prepared Project Quality Plans, Design Qualification (DQ), Bill of Materials (BOM), and FAT/SAT Protocols, along with Equipment Turn Over Packages (ETOP).
- Executed Factory Acceptance Tests (FAT) and authorized dispatch clearance for equipment.
- Provided team management and client coordination to streamline project execution.
- Developed and reviewed Standard Operating Procedures (SOPs), contributing to quality system improvements.
- Actively participated in external audits and project kick-off meetings.
Process and CQV Engineer
Hyde Engineering + Consulting
03.2016 - 08.2020
- Syngene International (API Manufacturing, Mangalore, India - Onsite C&Q): Prepared and executed Installation Qualification Protocols for Rotacone Vacuum Dryers, Glass Lined Reactors, SS Reactors, Centrifuges, Agitated Nutsche Filter Dryers, Vessels, and Vacuum Tray Dryers. Coordinated with vendors for mechanical completion and performed P&ID walk-downs and as-built preparation.
- Sanofi (Multi Insulin Facility, Frankfurt, Germany - Onsite CIP Design Review): Conducted sanitary walk-downs and categorized observations for process equipment and utilities to optimize CIP design.
- Immunomedics (Mammalian Cell Culture, NJ, USA - Offshore Process Design): Authored User Requirement Specifications (URS) for Chromatography and Column systems.
- Pfizer (Injectables, Chennai, India - Onsite C&Q): Executed P&ID walk-downs for Pure Steam, WFI, and Purified Water Generation, Storage, Distribution, and Point of Use systems. Prepared IOQ Protocols for Clean Utilities.
- Shantha Biotechnics Private Limited (QC Design, Medchal, India - Offshore Process Design): Prepared User Specifications Sheets for Biosafety Cabinets and Laminar Airflow Units. Developed data sheets for tabletop analytical instruments (TOC Analyzer, Benchtop-Centrifuge, Filtration Pump) and generated Equipment and Power Load Lists, Clean and Black utilities distribution layouts, and schematics.
- Pfizer (Injectables, Visakhapatnam, India - Onsite C&Q): Prepared and executed commissioning protocols for Mixing tanks, Holding tanks, Transfer Lines, and CIP Skids. Managed deviations and proposed CAPA. Prepared HVAC revalidation protocols.
- Syngene (Microbial Cell Culture, Bangalore, India - Onsite C&Q): Reviewed URS and ETOP documents. Defined system boundaries and acted as System Owner for the commissioning and qualification of CIP Station & Distribution System, Fermenter, Weighing Balances, Temperature Control Unit, Single-Use Mixing Systems, and Buffer Preparation Systems. Managed discrepancies and proposed corrective actions.
- Syngene (Mammalian Cell Culture, Bangalore, India - Onsite C&Q): Reviewed vendor documents (FAT & SAT). Prepared Commissioning and IOQ Protocols, RTMs, and IQ/OQ/IOQ Summary Reports. Served as System Owner for the commissioning and qualification of Single Use Bioreactors, Media and Buffer Preparation & Distribution Vessels, Single-Use Mixing Bag Holders, Single-Use Mixing Liner Holders, Single-Use Holders, Temperature Control Units, Deep Freezers, Data Loggers, and Table-Top Equipment.
- USV (OSD, Daman, India - Onsite C&Q): Reviewed vendor documents (DQ, FAT, SAT, IQ & OQ). Prepared RTMs and addenda to IQ & OQ Protocols. Executed IQ and OQ for pharmaceutical equipment including Vibro sifter, RMG, FBP, Multimill, Container Blender, and Weighing balances.
- Teruisi (Mammalian Cell Culture, China - Offshore Process Design & C&Q): Prepared Interface Automation Matrices, Functional Specifications, and Phase Interlocks. Developed Installation and Operational Qualification documents and RTMs. Reviewed Equipment and Drain layouts. Performed Process Control System (PCS) Bench Testing.
BCIL-BITP Trainee
Biozeen
10.2015 - 03.2016
- Gained hands-on experience in Microbial Fermentation with fully automated (SCADA linked) Fermenters and Media Preparation Systems, including ESIP, FSIP, CIP, and probe calibration.
- Developed expertise in Animal Cell Culture, mastering aseptic handling techniques, sub-culturing BHK-21 cell lines, bioburden quantification, cell counting, cell revival, growth curve studies, scale-up with microcarrier culture technology, bioreactor operation, and cryopreservation.
- Proficient in Downstream Processing, including primary purification (TFF, Microfiltration, Ultrafiltration, Diafiltration), secondary purification (Bio-Affinity, IEC, HIC, Gel Filtration chromatography), and electrophoresis techniques (Agarose gel electrophoresis, SDS-PAGE).
- Performed CIP, SIP, and Sterile Filtration activities, including P&ID preparation for various systems (Fermenter, Bioreactor, TFF, Media Prep, ATF, Inactivation Vessel, CIP Station/Skid), integrity testing of filters, spray ball coverage testing, and qualification of sterilizers (autoclave, DHS).
Education
Masters - Biotechnology
Andhra University College of Engineering
Visakhapatnam, Andhra Pradesh, India09-2015
Skills
- URS Preparation
- Design Review
- Mechanical Completion
- FAT/SAT/IQ/OQ/PQ
- E-Validation
- P&ID Walkdown
- Process Automation
- CIP/SIP
- Compliance to cGMP Guidelines
- Quality Management
- SOP Preparation
- Deviation Handling
- CAPA
- Change Control
- Audit Compliance
Equipment Expertise
I have experience in Upstream and Downstream process equipment packages Commissioning and Qualification such as Bioreactors, Fermenters, Media/Buffer Prep Vessels, Single-Use Systems, Harvest Systems, Chromatography, Filtration Skids, Utility distribution systems (Process Air, CO2, O2, PW & WFI), CIP, Autoclave, Clean room equipment (BSC, DPB, DGC, LAFU) , Cold chain equipments (Ultra-low deep freezers, deep freezers , Refrigeratorsand Cold room), Bio-kill Systems, Table-top Analytical Equipments (Solo VPE, BET Analyzer, Automated Cell Counter, TOC Analyzer, pH & Conductivity Meter, Magnetic Stirrer, Turbidity Meter, Benchtop Centrifuge, Filtration Pump & Weighing Balances)
Also, I have worked in API, OSD & Injectables facility process equipment packages Commissioning and Qualification such as SS/Glass Lined Reactors, Rotacone Vacuum Dryers, Centrifuges, Agitated Nutsche Filter Dryers, Vacuum Tray Dryers, RMG, FBP, Multimill, Container Blenders and Formulation Vessels.
Personal Information
- Date of Birth: 18 Aug 1992
- Nationality: Indian
- Marital Status: Married
Timeline
Assistant Manager | CQV & CSV
Syngene International Limited
03.2021 - 06.2025
Assistant Manager | Quality Assurance – Validation
DD Enterprises
09.2020 - 02.2021
Process and CQV Engineer
Hyde Engineering + Consulting
03.2016 - 08.2020
BCIL-BITP Trainee
Biozeen
10.2015 - 03.2016
Masters - Biotechnology
Andhra University College of Engineering
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