Prem Reddy Email & Phone Number

Hayward, California, United States

• Involved in compliance review and coordination of vendor protocols for protocol generation, execution, and summary of various pieces of new equipment such as Tanks, CIP skid, TFF skids, Spray dryers and Isolators.• Involved in designing procedures and test methods which comply with business, FDA and industry best practice guidelines: FDA’s 21 CFR820 and 11; ISO 14971 and 13485, GMP and GAMP 5• Collected and analyzed user requirements and detailed design specifications, functional requirement specifications to develop VMP, SAT, IOQ’s and risk analysis.• Involved in the development of Requirement Traceability Matrices (RTMs) for spray dryer.• Maintaining and updating Requirement Traceability Matrices (RTM) to track requirements that co-related with the conducted test cases for Isolators, CIP and TFF skids.• Authored documents independently such as Validation Master Plan (VMP), Site Acceptance Testing (SAT), Installation and Operational Qualification (IOQ) and final reports for tanks, spray dryer and isolator.• Developed Clean-in-place (CIP)/ Sterilization-in-place (SIP) cycle development, spray coverage testing, sample testing and parameter calculation for CIP skid, TFF skid, spray dryer, tanks and isolators.• Developed IQ, OQ, and PQ of fully automated CIP skids for cleaning of all types of equipment; Spray dryer, tanks and TFF skid.• Reviewed pFMEA (Process Failure Mode and Effect Analysis) to assess risk of equipment on process and to establish Risk Controls to mitigate and reduce risks.• Generated a cleaning validation procedures and site cleaning validation program.• Reviewed the system related SOPs to ensure compliance of company’s processes, policies, and procedures.

New Jersey, United States

• Performed and executed Validation, Qualification and Re-Qualification protocols for the Manufacturing Equipment /Process and aseptic areas.• Validated equipment’s such as chromatograph, bioreactors, autoclaves, and Incubator in compliance with FDA regulations. • Prepared and executed Validation and Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) for process equipment’s such as autoclaves, mixers, Bioreactors, Tanks, and Lyophilizes in compliance with cGMP and FDA regulations.• Performed temperature mapping, thermocouple calibration, sterilization, heat distribution, penetration, three biological indicator studies for various process equipment’s.• Drafted standard operating procedures (SOPs), and supported QA audits of existing operating procedures to ensure the compliance with company current regulatory requirements.• Well versed with FDA regulations and working knowledge of cGMPs and documentation requirements including 21 CFR 11, 210, and 211.• Wrote validation summary reports for chromatography system, bioreactors, autoclaves, and purification systems.• Ensure that all the documentation is compliance with FDA and CGMP regulations and provides technical support to the validation group as needed.• Authored validation documents independently such as OQ and final summary report for the retrospective qualification of HPLC columns.• Authored validation documents such as IOQ for the qualification of new replacing HPLC columns• Executed Operational Qualifications (OQs) to make sure that the columns are capable of consistently operating between established limits and tolerances.• Ensured complete 21CFR part 11 compliance assessments for manufacturing systems.• Wrote discrepancy reports, SOP’s and other technical documents about the verification studies.

India

• Worked on performing Root Cause analysis and implemented Corrective and Preventative Actions (CAPA), for product and process related concerns.• Provide Technical guidance and design assurance as it relates to design inputs, outputs, verification, and validation activities. Participate in audits and audits findings.• In-depth knowledge of medical device reprocessing; including sterilization validations and material biocompatibility • Responsible for product design and development which includes Creating part and assembly drawings, fabrication drawings and specifications which are required for equipment design and fabrication using Solid works and Windchill for products.• Developed and performed Design of Experiments (DOE) and gage R&R tests. • Drafted equipment cleaning SOPs for use by manufacturing personnel in daily operations.• Performed Cleaning validation sampling and monitoring during the execution of various product and their corresponding stages. • Performed TOC, visual inspection and TOC swab sampling to support cleaning validation projects as departmental needs dictate.• Generated verification protocols for internal and external testing fixtures to verify the design met its requirements for intended use and to meet various regulatory standards for safety compliance. Generated documentation to report and discuss engineering design analysis and testing findings, technical memorandums, and follow up risk management report.• Analysis of validation case studies and hands-on validation engineering training. • Performed GAP Analysis and developed the corresponding Remediation Plan.• Overview of piping and instrumentation diagrams (P&IDs). • Write, perform, and review validation protocols and reports (IQ/OQ/PQ).• Responsible for Process FMEA/Production Risk Management Remediation to ensure high level of compliance to FDA QSR 21 CFR 820, ISO 13485 and ISO 14971 in all assigned areas.