Akhil Voruganti
IL
Summary
Quality and Manufacturing professional with expertise in Manufacturing,GMP biologic's production, quality assurance, Project Engineering and continuous improvement. Skilled in upstream/downstream operations, cGMP compliance, CAPA, root cause analysis, and cross-functional collaboration to support technology transfer, equipment qualification, and process optimization. Experienced in Lean Six Sigma, value stream mapping, Kaizen, and statistical analysis (Minitab) to drive efficiency and reduce cycle times. Holds dual master's degrees in quality engineering & management (USA) and Engineering Management (Italy), with PMP Certification. Recognized for strong leadership, business acumen, and communication skills, consistently delivering compliance, efficiency, and value in pharmaceutical manufacturing.
Overview
3
3
years of professional experience
1
1
Certification
Work History
Manufacturing Documentation Specialist
Baxter International
Round lake, Illinois
02.2026 - Current
- Review and verify batch production records in real-time to ensure compliance with cGMP and GDP standards
- Perform yield reconciliation and critical process parameter verification to ensure data accuracy and prevent compliance risks
- Cross-reference executed batch records against Master Batch Records (MBR) to validate process adherence
- Identify documentation discrepancies, quality risks, and process deviations; escalate to Quality and Manufacturing leadership
- Monitor in-process checks and ensure completeness of production documentation
- Provide on-floor documentation guidance to manufacturing operators to reinforce data integrity standards
- Drive Right First Time (RTF) performance by supporting the delivery of error-free batch records requiring no manufacturing intervention following Quality review
- Implement and maintain real-time documentation checklists on the production floor, ensuring completion during operations rather than post-process
- Utilize structured checklists to capture errors identified, gaps observed, actions taken, and required follow-ups, improving documentation accuracy and traceability
- Partner with Manufacturing and Quality teams to proactively resolve documentation gaps and prevent recurring issues
- Support deviation investigations and CAPA documentation activities
- Participate in internal audits and contribute to audit readiness initiatives
- Assist in continuous improvement efforts targeting documentation accuracy and operational efficiency
- Maintain structured documentation control and retrieval systems in compliance with regulatory requirements
Manufacturing Technical Associate III
Catalent Pharma Solutions
Baltimore, Maryland
09.2023 - 02.2026
- Execute upstream and downstream GMP biologics manufacturing operations, including buffer/media preparation, bioreactor/fermentation, and chromatography purification steps, ensuring compliance with FDA and global regulatory standards.
- Complete and review Batch Production Records (BPRs) and Standard Operating Procedures (SOPs) with 100% accuracy, supporting audit readiness and regulatory compliance.
- Support deviation investigations and CAPA closures; partner cross-functionally with QA, MS&T, and Facilities to troubleshoot equipment and process deviations, minimising downtime and maintaining product quality
- Collaborate with Process Development and Manufacturing Sciences & Technology (MS&T) to successfully transfer new projects into GMP manufacturing.
- Assist with equipment qualification, validation, and facility expansion initiatives to support scale-up and commercial readiness.
- Provide client support during manufacturing campaigns, including escorting and ensuring compliance of Person-in-Plant (PIP) representatives.
- Recommend equipment and material improvements that enhanced process efficiency and reduced operational delays.
- Maintain strict adherence to cGMP, EHS, and safety protocols, ensuring safe and compliant operations on the production floor.
- Supporting, fostering Continuous improvement initiatives and actively participating in CI Workshops for efficiency in procurement and Production
Education
Master of Science - Quality Engineering and Management
Southern Illinois University-Carbondale
Carbondale, IL, USAMaster of Science - Engineering Management-Business Engineering
University of Salento
Lecce, ItalyBachelor of Technology - Mechanical Engineering
Anurag Group of Institutions
Hyderabad, IndiaSkills
Quality Assurance, Statistical Analysis, Quality Management Systems, continuous improvement, Root cause analysis
Teamwork and Collaboration Quality auditing, Minitab, Leadership, Change management, process improvement, Project Management, Business planning, presentation Skills, Teambuilding, conflict resolution, communication and presentation, Microsoft Office, Azure, Business Acumen, Lean Six sigma, Supply chain Optimization, BPM, Value stream mapping, Kaizen Events, Attention to Detail,5SPrinciples, ERP Systems, CAD/CAM, Reliability Analysis, CGMP, CAPA, Root Cause Analysis, Python, Business Management
Websites
Certification
- Project Management Professional (PMP)
- Project Management Institute (PMI),USA
- Lean Six Sigma Certificate, Professional Development Sequence (PDS) Southern Illinois University, Carbondale, IL, USA
- PMI Certification for attendance (Project Taxi mate) Project Management Institute, Southern Italy (PMI), ITALY
- Master Certificate in Computer Aided Tool Engineering (MCTE) Central Institute of Tool Design ,Hyderabad ,India
Timeline
Manufacturing Documentation Specialist
Baxter International
02.2026 - Current
Manufacturing Technical Associate III
Catalent Pharma Solutions
09.2023 - 02.2026
Master of Science - Engineering Management-Business Engineering
University of Salento
Bachelor of Technology - Mechanical Engineering
Anurag Group of Institutions
Master of Science - Quality Engineering and Management
Southern Illinois University-Carbondale
INTERNSHIPS
- Six Sigma Black Belt project (DMAIC) AISIN Electronics, Marion, Illinois
The assembly line optimization project at AISIN Electronics aimed to reduce cycle time from 28 to 25 seconds for memory seat control unit production. The team applied Six Sigma tools, including SIPOC, Kano Model, and Value Stream Mapping, to analyze bottlenecks and improve efficiency. Initially, the line had three workstations with unbalanced process times, causing bottlenecks. A redesigned layout was proposed, redistributing tasks to balance workload and minimizing downtime. The project emphasized maintaining product quality while improving efficiency. Key concepts used included cycle time reduction, workload balancing, lean manufacturing principles, and continuous improvement. The team focused on reducing walking time and balancing individual process times across workstations. While the outcome isn't explicitly stated, the proposed modifications significantly improved process flow and workload balance
- Business Management intern, Leadership development Resilience, Florida, Remote
Served as a Leadership Development Business Intern, focusing on enhancing leadership skills and understanding business operations. Assisted in developing and implementing strategic initiatives, conducted market research, and analyzed data to support business decisions. Collaborated with cross-functional teams to streamline processes and improve efficiency. Participated in leadership training programs, gaining insights into effective management practices and organizational development. Successfully contributed to projects that fostered innovation and growth within the company.