LENKA PRASADARAO

• Process knowledge: Aseptic manufacturing, visual inspection(SME),Terminal sterilization process (SME),investigations,Documentation and compliance.
• Supply: Manage end-to-end shift operations, and ensure the filling and sterilization of products within the hold time.
• Quality: Ensure 100% compliance with procedures and practices; identify, investigate, assess, and prevent non-compliances; lead the process improvements,change controls, audits, compliance, and process validations.
• People: Develop colleagues' capabilities, minimize attrition, recognize, and provide opportunities for growth in all ways possible.
• Financials: Manage budget vs. Recoveries and cash flow in the TS area, achievement of targeted schedule adherence, and capacity utilization.
• Led a diverse team of 90 members, improving team performance through coaching and mentoring.
• Completed two process improvement projects and was certified as a 'Six Sigma Yellow Belt.'

• Perform investigations using 'Method 1'—DMAIC methodology, identify the root cause, and CAPA.
• Completed one process improvement project and certified as a 'Six Sigma Yellow Belt.'
• Operated advanced sterilization equipment to maintain operational efficiency.
• Led a team that contains 12 members.
• Responsible for five static superheated water sterilizers, and one rotary superheated water sterilizer.

• Proven capabilities of end-to-end terminal sterilization operations.
• Involved in SAT, IQ, OQ, PQ, and PRQ of sterilizers.
• Oversaw daily operations, ensuring compliance with regulatory standards and company policies.
• Implemented process improvements that streamlined workflows and increased operational efficiency.

Operations of the vial filling machine (Bausch + Strobel), Skan glove integrity, sterile isolators, VHP, and sterilizer operations.