Suchitha Peenya Basavalingaiah

- Executed Lean Six Sigma methodologies to enhance process robustness and yield improvement.
-Managed project timelines and resources, while ensuring effective stakeholder communication under PMP guidelines.
- Led investigations into deviations, implementing CAPAs to promote ongoing improvements.
-Collaborated across departments including QA, QC, Regulatory Affairs, and Engineering for campaign execution.
- Authored and reviewed SOPs, along with batch records, risk assessments, and validation protocols (IQ/OQ/PQ).
- Facilitated tech transfer of autologous cell therapy processes into GMP-compliant manufacturing environments.
-Delivered on-floor technical support for upstream, downstream, and fill-finish operations.

• Responsible for process requirements in capacity expansion.
• Conducted trials, observed process conditions and analyzed results to improve product quality and reduce costs.
• Led continuous improvement projects, applying Six Sigma and Lean manufacturing principles.
• Performed testing on prototype medical devices to ensure safety and efficacy.
• Identified potential risks associated with new technologies prior to implementation.
• Developed process designs for new and existing manufacturing processes.
• Assisted in the development of process validation protocols and reports for medical device manufacturing processes.

• Developed and analyzed statistical data and product specifications to determine standards and establish proposed quality expectancy of the finished product.
• Established regulatory guidelines for Class I, Class II, Class III, and Class IV medical devices. Responsible for the submission of medical devices to the FDA and GUDID.
• Managed process improvement projects from initiation to completion, ensuring deliverables are met within agreed timelines and budgets.
• Developed and implemented quality assurance processes to ensure product compliance with customer requirements.
• Assisted with supplier evaluation activities including vendor selection based on criteria such as cost effectiveness, delivery times.

• Implemented innovative ideas for increasing productivity while reducing waste output.
• Developed strategies for improving product quality while minimizing production times.
• Evaluated existing processes for efficiency improvements and cost savings initiatives.
• Collaborated with other departments such as Quality Assurance and Maintenance to ensure optimal performance of the production line.
• Performed regular maintenance checks on all equipment used in the production line.
• Analyzed data from experiments to determine best practices for current processes.
• Conducted trials, observed process conditions and analyzed results to improve product quality and reduce costs.

• Responsible for achieving savings in managing the commodity, Enterprise Solutions. This involved RFPs, price negotiation, vendor selection, contracts management, client relation management, and vendor management for the projects across India and South Asia.
• Proven analytical and problem-solving abilities. Strong customer service orientation.
• Assisted in sourcing discussions to build a green data center, which was then emerging in the organization globally.
• Developed and implemented procurement strategies to ensure cost-effective purchases of materials, supplies, and services.
• Negotiated and finalized vendor contracts in order to optimize pricing structures and delivery schedules.