PRASAD VISSAKOTI

Results-focused candidate with strong academic foundation and relevant work experience. Demonstrates readiness to take on new responsibilities and meet performance expectations. Applies diligence and accountability to deliver dependable outcomes.

• Led the successful implementation of the 5S methodology, earning recognition and an award from senior management.
• Executed and supported the successful commercial launch of a peptide molecule (Liraglutide) with 100% Right First Time (RFT) compliance, receiving an excellence award.
• Recognized for significantly improving Turnaround Time (TAT) from 31 days to 11 days, and optimizing SPA processes for commercial and validation batches.
• Achieved major cost-saving milestones as part of a Lean project, successfully meeting yearly QC budget targets.
• Recognized and awarded for demonstrating business continuity through exceptional customer satisfaction and operational excellence at Syngene International Ltd.
• Honored for significant contributions to outstanding performance, ensuring the timely release of critical deliverables.
• Certified by Syngene International Ltd management for the successful completion of the prestigious 'Train the Trainer' program.
• Recipient of the SPOT-ON Awards for delivering complete calibration support with zero deviations, accurate reporting, and ensuring zero reprocessing of chromatographic data, as well as driving cost reduction initiatives during AMC and CMC filing discussions with vendors.
• SLT member on the new TPM (Total Productive Maintenance) JIPM (Japan Institute of Plant Maintenance) Certification project.

The above-said information is true and correct as per the best of my knowledge and belief. I assure you that if you give a chance to serve in your esteemed organisation. I will perform to the best of my ability. Place: Vishakhapatnam, Date: Yours Sincerely, PRASAD VISSAKOTI

• Contributed To the Success Of USFDA, EDQM, TGA, HEALTH CANADA, PMDA And Audits.
• Handled ISO, And Various National and International Customer Audit.

• Procurement and qualification of Analytical instruments. (Instrument and software qualification, DQ, IQ OQ and PQ).
• Validation of Application software's. (Ex: Empower, chromeleon, Lab solution & Tiamo etc....)
• Handling of CSV activities such as System Classification Assessment (SCA), User Requirement Specification (URS), Validation plan (VP), Functional Requirement Specification (FRS), Functional Risk Assessment (FRA), Design Specification (DS), Qualification plan (QP), IQ, OQ, PQ. Validation summary reports & System Release Certificate.
• Categorization and qualification of Analytical Instrument as per the (USP) general chapter on Analytical Instrument qualification (AIQ) as per the Qualification plan (QP), IQ, OQ, PQ.
• Perform CSV (Computerized System Validation) for the Standalone Systems.
• Implementation of Laboratory requirement and enhancements to increase efficiency and ensure compliance. (ALCOA++ Principles)
• Preparation, review and approval of CSV documents in line with 21 CFR Part 11, GAMP5, GDP, GDPs and regulatory requirements.
• Audit trial & Date and time verification.
• Review of analytical documents through Electronic Document Management system. (EDMS).
• Review of analytical documents through Electronic Laboratory Note book (ELN).
• Review of analytical documents and work allocation through Laboratory Information Management System (LIMS).
• Worked as team leader of GLP team (Calibrations & maintenance of working standards and Impurities, and qualification of instruments.)
• Preparing and monitoring of calibration and preventive maintenance schedules of QC instruments.
• Coordinating with vendors and monitoring of preventive maintenance of QC instruments.
• Preparing and maintenance and Qualification of working standards and In-house reference standards. Responsible for procurement of reference standards and Qualifications of Working Standards & In-house Reference Standards
• Preparation and implementation of SOPs
• Initiating change controls related to the quality control requirements (i.e. periodic review of SOPs, installation of new instruments, implementation of documents impact to incidents & CAPA) and providing training to all concerned personnel.
• Procurement and indenting laboratory instruments as per company requirements.
• Handling and maintaining of Quality control budget and financial planning.
• Approvals and renewals of laboratory instruments and equipment maintenance planes of AMC, CMC.
• Audit preparedness and providing compliance
• Maintaining and review documentation such as laboratory notebooks, electronic data, instrument logbooks, Calibration records, Working standard qualification records & training records etc.
• Handling of QMS Activities Change controls, Deviations, Out of Calibrations through Track wise and Investigation of the same.
• Handling of Out of specification (OOS), Out of trend results (OOT), and Deviations/Incidents generated in the Quality control laboratory according to the respective procedures and regulatory requirements.
• Performing RCA (Root Cause Analysis) using different tools for various aberrations as part of investigations and proposing and implementing appropriate CAPAs for the same
• Review and approval of Corrective and Preventative Actions (CAPA); including tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness.
• Handling of laboratory Incidents and trending.
• Conducting the awareness training, skill enhance and qualification of analysts on the various analytical techniques for new joiners.
• Active involvement in all major projects in Quality Control.
• Review the Analytical Documents and Checking System audit trials in different types of software's (Ex: Empower, Chromeleon and Lab solution software.)
• One of the team members in internal audit team, for Auditing of inter units of related departments.
• Performing the Analysis of Raw materials, Intermediates, in process materials & finished products.
• Preparation & maintenance of Standard solutions & Indicator solutions.
• Perform the stability study Analysis as per monthly scheduled & Maintain Related stability Chambers
• Analytical method transfers as per customer requirement
• Calibrations of instruments according to their respective schedules.
• Supporting to the Regulatory Affairs regarding to customer complaints.
• Followed preparation of Raw Data Sheets & STP'S for all products.
• Participate in Operation Excellence initiatives and continuous improvement projects (Eg: GEMBA and GMP walk).
• Lead the 5S activity for improving the Laboratory activity.