Gonthina Ashok

• Working as a CQV Engineer for a Novo Nordisk 25LProject in Denmark.
• Led commissioning and qualification of clean and black utility systems, including purified water,WFI, clean steam, HVAC, and compressed air.
• Ensured adherence to design specifications and GMP compliance during system installation and operation.
• Developed and executed IQ, OQ, and PQ protocols to validate system performance and regulatory compliance.
• Conducted risk assessments and gap analyses to mitigate compliance issues.
• Prepared and maintained comprehensive CQV documentation, including validation plans, URS, and FDS.
• Delivered audit-ready reports to ensure regulatory readiness.
• Worked with engineering, operations, and quality assurance teams to troubleshoot utility system issues and optimize performance.
• Provided technical expertise during inspections and audits
• Maintained compliance with FDA, EU, and other international regulatory requirements.
• Recommended system improvements based on industry best practices.

• Worked as engineer, executing commissioning and qualifications for engineering projects process equipment's and water system.

Projects Handled:-

• PW generation and distribution system, WFI generation, Pure Steam generation system, WFI distribution system process vessels, etc.

Roles and Responsibilities:-

• Managing project-related documentation such as User Requirement Specifications (URS), Functional Design Specifications (FDS), Design Qualification (DQ), Hazardous Data Sheets (HDS), Safety Data Sheets (SDS), Factory Acceptance Tests (FAT), and Installation and Operational Qualifications (IOQ).
• Collaborating with Cross-Functional Teams (CFT) to ensure timely completion of project and production-related activities.
• Preparing various documents including Project Specific Quality Plans (PSQP), URS, and Standard Operating Procedures (SOPs) required for project execution. Involving in new block project development, process cross checks, URS discussions and monthly meetings with the vendors regarding project development.
• Preparation of standard operating procedure.
• Follow up with vendors for service and material. Responsible for attending the equipment preventive maintenance, General maintenance and breakdown Maintenance.

Worked as Shift Engineer in Operation & maintenance of water system, Utilities & Engineering Documentations.

Roles and Responsibilities:-

• Responsible for Installation, Qualification & operation and maintenance of Pre-treatment and purified water system. Responsible for Installation, Qualification and operation and maintenance of Air compressors and nitrogen plants.
• Responsible for Installation, Qualification and operation and maintenance of water cooled chillers and brine chillers.
• Responsible for Installation, Qualification and operation and maintenance of Furnace oil boiler.
• Review of Technical documents, P& ID, specifications & data sheets, Compliance certificates, and drawings. Always supervise the Project's online documentation with respect to Equipment, Qualification, Re-Qualification, Thermal Mapping, Training, and Re-Evaluation.
• Coordination with PMC Team for the daily Construction and Installation activities and raising Project Change management as per the requirement and procedure.
• Ensuring all CQV work activities are performed as per regulatory and compliance and safety requirements.
• Identify bottlenecks and activities and overcome them for smooth project C&Q activities.

Roles and Responsibilities:-

• Providing onsite support to client, Ensure smooth installation of system.
• Installation and qualification of Process vessels, MGF, Softener, Duplex softener, UF, RO (CSRO & HSRO) & EDI.
• Leading onsite fabrication team of 4-15 members, Adhering with Client Safety Requirements, On Site Installation and Qualification of Clean Utilities systems like Purified Water, Water for injection, pure steam along with Distribution Loop Plant Checkup includes Problem identification, Preventive measures & Corrective methods.
• Efficient in all types of trouble shooting Chemical cleaning, Media replacement, Regenerations. AMC visits includes trouble shooting, calibrations & maintenance.
• Maintaining water parameters as required and water analysis as per system requirement. Dosing pump calibrations, Dead leg verifications, Passivation, Slope verifications.

Worked as a Supervisor in CN Water for Dr.Reddys laboratories FTO SEZ PU02,

Roles and Responsibilities:-

• Supervision of Plant O&M and ensuring all the water parameters as per the design Managing operators for the smooth operation of the water system.
• Ensuring all the activities performed like chemical preparations, Tank Cleaning, Concentrations to dosing percentage maintenance.
• Trouble shooting of all the equipment involved in the system and assuring Good Documentation practice and Good Manufacturing Practice.
• Operation of water system, maintaining of parameters. Dosing chemical preparations and media replacement.
• Following GMP by following SOP and ensuring all parameters under design specifications.