Kvsn Murthy Talabathula
CSV (Computer System Validation) - ITRA
Hyderabad,TG
Summary
- Dynamic IT Quality Assurance Executive with extensive experience at Chemo India Formulation Private Limited, skilled in 21CFRpart11 compliance and risk-based validation. Proven track record in leading successful digital transformation projects and enhancing quality systems. Adept at training teams and implementing effective QMS solutions, ensuring regulatory adherence and continuous improvement.
- · Perform assessments of computer systems and processes for Life Sciences clients (compliance with internal procedures, leading practices, and regulatory requirements)
Overview
11
11
years of professional experience
1
1
Certification
Work History
IT Quality Assurance Executive
Chemo India Formulation Private Limited
06.2024 - Current
- Lead the qualification and implementation of the TrackWise Migration of manual documents into Document Management System (DMS) and Training Management System(TMS).
- Handle implementation of serialization of the track and trace for digital transformation in packing bottle line and blister line.
- Handle qualification of the characterization lab, Sceix OS, HRMS,PPSQ,molecular profiles qualification activities in CIF
- Handle qualification of PRODRE of robotic audit trail implementation and qualification in CIF.
- Handle qualification of the Minitab software, new bioanalytical lab creation(Euro thermal & Sceix OS ),
- Handle qualification external warehouse(Area Qualification & RLAF ), Granulation-2 projects.
- Handling the qualification and implementation of SAP in CIF QA,MM and WH modules in CIF.
- Preparation and Review of validation deliverables such as project validation plans, URS (User Requirement Specification), IRA (Initial Risk Assessment), Functional Risk Assessments as per validation master plan, IQ, OQ, PQ, Traceability Matrix, Summary reports and Project Validation Reports.
- Equipment’s/instruments qualification activities with Ensure compliance and further development, support, maintenance and constant review of the Quality Systems and support for projects (formulations and API plants.)
- Ensuring implementation of effective and efficient processes that fulfill regulatory requirements.
- Agile methodologies fundamental which including knowledge of scrum & kanban tools.
GXP IT Quality Assurance
Sri Krishna Pharmaceutical
11.2021 - 06.2024
- Validation of GXP IT systems like LMS,DMS and Quality systems and server migration.
- Preparation and reviewing the GXP test document like Test plans, OQ & PQ Test Script, Risk Assessment and traceability matrix for applications, validation summary reports.
- Computer system development in line with SDLC (software development life cycle)
- Team lead in e-BMR/BPR project for electronic document preparation and training.
- Executing the test script of the CSV PQ protocols to qualifying the application of software in serversas per the 21CFRpart11.
- Executing the Data restoration and server migration test scripts as per the 21CFRpart11.
- Handling of qualification of Computer system validations (CSV) activities QMS (varda IT solutions ),e-BMR(Atachi in cloud server ), Ikon , e-cal software’s track and trace system and profix PACK i software ).
- Handling QMS (varda IT solutions ) activities (Change controls, Deviations, Risk assessments ).
- Preparation and Execution of Project Plan for Digitization of Pharma manufacturing process.
QA Executive
Aurobindo Pharmaceuticals
05.2017 - 11.2021
- Resolve the process and anticipate quality problems through continually improve and harmonize the quality-relevant processes.
- Support regulatory risk management through identification, assessment, mitigation and communication.
- AHU Qualifications ,HVAC system validations and Temperature and RH mapping as per schedule ensuring .
- Purified water system qualification with generation, storage and distribution.
- Reviewing the Artworks design of printedfoils ,pills and cartons based on MPC / Regulatory requirements of customers packing (hormony software).
- Preparation, Issuance, Retrieval and handling of documents like SOPs, Batch records, Analytical work sheets and other master documents as a document controller. Archival of master and executed documents for the future evidence and handling of audit purpose.
- Ensuring implementation of effective and efficient processes that fulfill regulatory requirements.
QA Officer
Micro Labs Private
07.2015 - 04.2017
- Maintained up-to-date knowledge of industry trends and advancements in Quality Assurance methodologies.
- Conducted thorough inspections for identifying defects and ensuring adherence to quality standards.
- Reduced customer complaints by proactively addressing product issues before release.
- Collaborated with cross-functional teams to identify areas of improvement in production processes.
- Actively participated in process improvement initiatives that led to significant reduction in overall project timelines.
QA Officer
MEDREICH
03.2014 - 06.2015
- Maintained up-to-date knowledge of industry trends and advancements in Quality Assurance methodologies.
- Conducted thorough inspections for identifying defects and ensuring adherence to quality standards.
Education
Master of Science - Pharmaceutical Technology
Aditya College of Pharmacy
Kakinada, India 04.2001 -
Skills
Experience in Quality and Compliance with hands-on computer system validation complies the 21CFRpart11
Certification
[Information security management systems ] Training -2023]
Timeline
IT Quality Assurance Executive
Chemo India Formulation Private Limited
06.2024 - Current
GXP IT Quality Assurance
Sri Krishna Pharmaceutical
11.2021 - 06.2024
QA Executive
Aurobindo Pharmaceuticals
05.2017 - 11.2021
QA Officer
Micro Labs Private
07.2015 - 04.2017
QA Officer
MEDREICH
03.2014 - 06.2015
Master of Science - Pharmaceutical Technology
Aditya College of Pharmacy
04.2001 -
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