Applications: TrackWise, Maximo, LIMS, Werum PAS-X, EDMQ, SAP, ERP,Batch Trace Reporting system(BTRS), Global Drawing Management System (GDMS), Minitab, CDOCS, Delta V, RT reports, Smart Sheets
Venkata Mani Teja Nagubandi
Senior Associate QA
100 Elena St, Apt-305, Cranston,RI
Summary
A dedicated Quality and compliance professional with more than 4 years of experience in the pharmaceutical and biotechnology industry. I have a thorough knowledge of Drug Development, Drug Substance, and Drug Product standards and applying them in a cGMP, cGLP & cGCP organization. I have contributed to the creation and standardization of Good Documentation Practices (GDP) at both developing and mature manufacturing site and have used various techniques to train quality/manufacturing staff in appropriate methods to ensure product quality and inspection readiness .
Overview
5
5
years of professional experience
5
5
years of post-secondary education
Work History
Senior Associate Quality Assurance
Amgen Incorporated - West Greenwich, RI
07.2019 - Current
- Regulate sequence of operations to assemble and accumulate parts or products, assess quality documents, such as SOPs, user requirements, risk assessments, training materials, engineering, automation, commissioning, environmental qualification, validation
- Involved in AR30 facility start up activities and provided QA support as needed
- Actively participated in New Product Introduction(NPI) activities
- Supporting Process and cleaning validation activities
- Providing QA support for change controls, Deviations and CAPAs
- Serving as QA point of contact for creation of Bill of material(BOMs) and MBRs(GMBRs, PVLs and PMBRs)
- Underwrite execution of, and change management related to factory acceptance, commissioning tests, facility qualification and validation activities
- Execute daily operations per management guidance in a dynamic environment
- Working as Quality representative for assigned focus areas such as Information Systems, Supply Chain and Owner supplied equipments
- Involving in Data Integrity Assessments and provide inputs as Quality
- Performs On the floor (OTF) quality review of documents, such as equipment logs, training records, testing results, batch records and supporting documents
- Performs daily OTF inspections to ensure facilities, equipment, materials and documentation comply with SOP’s and safety standards
- Provide guidance during on-the-floor analytical testing;
- Aid audits, inspections and investigations;
- Drive LEAN practices to contribute to culture of continuous improvement
- Drive operational improvements initiatives, programs and projects
Quality Engineer
Amgen Incorporated (MedPharma IT Solutions) - Woburn, MA
10.2017 - 07.2019
- • Provided support to Change Controls (CC), Deviations, CAPA’s as a Quality contact using Track wise
- Reviewed and Approved validation protocols (IQ, OQ, PQ) and Validation Summary Reports (VSR) for adequacy, completeness and compliance with Quality System requirements
- Participated in Root Cause Analysis session to determine appropriate casual factors, corrective or preventive actions
- Involved in preparation and review of Data Integrity Assessments(DIA), Engineering Test protocols (ETP), and Periodic reviews for Standard Operating Procedures(SOP), Computer related system and level 1 equipment
- Performed Acceptable Quality Limit (AQL) visual inspection for non labelled and labelled vial
- Provided on the floor(OTF) Quality support for all critical operations
- Involved in planning and executing product, process and equipment validations in accordance with FDA and ISO guidelines
- Reviewed and approved EBR's by ensuring all electronic batch records are in compliance with site procedures and cGMP regulations using Werum PAS-X software
- Reviewed and approved SOP’s in EDMQ in accordance with company policies and GMP
- Processed and approved Work order’s and Job Plans using Maximo and verified Sample ID’s through LIMS
- Involved in MBR’s revision and ensured that changes are aligned with associated Quality records
- Reviewed and Approved Bill of Materials (BOM) using SAP ERP
- Reviewed and Approved plant design layouts using GDMS
- Involved in product complaint assessments
Quality Analyst
LEARNBEYOND INC – South Plainfield, NJ
04.2017 - 10.2017
- Gathered and documented User Requirement Specifications (URS) and Functional Requirement Specifications (FRS)
- Developed, documented and maintained functional test cases and other test artifacts like test data and data validation
- Involved in writing and executing test scripts to validate certain functionalities in LIMS
- Created Requirement Traceability Matrix(RTM) to track requirements and co-relate with conducted test cases.
- Verified that all projected data is loaded into data warehouse without any data loss and truncation
- Verified that ETL application appropriately rejects, replaces with default values and reports invalid data
- Ensured that the validated deliverables meet functional and design specifications and requirements
- Hold and facilitated test plan/case reviews with cross-functional team members
Education
University of Central Missouri
Warrensburg 08.2015 - 12.2016
Jawaharlal Nehru Technological University
06.2010 - 05.2014
Skills
Certifications: ASQ CQA, Lean Six Sigma Yellow Belt
Quality: cGMP, GMP, cGLP, GDP, Lean/Kaizen Methodology, Six-Sigma, FMEA, Risk Analysis, CAPA, Deviation, Change Control, Acceptable Quality Limit (AQL), Aseptic-Sterile process, Validation Protocols (IQ, OQ, PQ), Process Validation, Agile, Water fall
FDA Regulations: 21 CFR Part 11, 210, 211, 820 and ISO 13845
Software
Office Tools: MS Word, MS Excel, MS PowerPoint, MS Outlook, MS Project, Sharepoint
Designing Software: AutoCAD, CATIA V5, MAT LAB, Ansys
Database: Microsoft SQL server
Timeline
Senior Associate Quality Assurance
Amgen Incorporated - West Greenwich, RI
07.2019 - Current
Quality Engineer
Amgen Incorporated (MedPharma IT Solutions) - Woburn, MA
10.2017 - 07.2019
Quality Analyst
LEARNBEYOND INC – South Plainfield, NJ
04.2017 - 10.2017
University of Central Missouri
08.2015 - 12.2016
Jawaharlal Nehru Technological University
06.2010 - 05.2014