SUMMARY OF QUALIFICATIONS

• Extensive experience in a regulated environment (FDA, EU, MHRA, ICH, QSR and 21 CFR Part 210,211, 11, 600, 608, 610, 820, 1271, EN 285 and ISO standards 9001, 13485, 19011, 31000).
• Ten years of professional experience in cGMP, GTP, GXP for Pharmaceutical, Biotech and Medical Device manufacturing.
• Experience in supervising validation consultants and technicians and overseen equipment, facilities, utilities, processes and software validation activities.
• Extensive experience in Validation Program, Corrective and Preventive Action (CAPA) Systems, Environmental Monitoring Program, Calibration and Preventive Maintenance Program, Internal and External Audit, Risk Management, Change Control, Batch Record Review, Training Program and Clean Room/Aseptic Environment .
• Authored, executed, reviewed and approved protocols to meet Validation requirements for Process Validation, Cleaning Validation, Equipment, Facility and Utilities Validation (WFI), Computer Systems Validation, Laboratory Instrument Validation, Media Simulation and Sterilization Validation. Documents range includes full spectrum - Master Validation Plans, SAT, FAT, URS, FRS, Impact Assessment, Development Study, IQ, OQ, PQ, PV and CV.
• Project Management experience in handling project life cycle including design, vendor selection, audit, system testing, commissioning, validation, operation, maintenance and as well as meeting all project timelines and goals.
• Worked on the team to develop a Process Validation strategy of serotype production for the regulatory submission of new vaccine Prevnar 13.
• Developed a validation strategy to reduce cycle time by 2 days and to increase operational capacity for Product Transfer Skid to download purified Polysaccharides.
• Conducted Risk Analysis for several Quality Systems.
• QA mandatory approver on Manufacturing Investigation Reports (MIR's) in Trackwise and SAP.
• Six sigma tools and certified red belt and working on yellow belt certification.
• Trained on ASTM-E2500 which covers the science and risk based approach to verification of equipment and systems.
• Team player, problem solver and willing to travel.

EDUCATION

Master of Pharmaceutical Engineering
Bachelor of Science - Chemical Engineering,

PROFESSIONAL EXPERIENCE

Sr. Quality Assurance Validation Associate Feb 2010 - Present
Confidential, Breinigsville, PA

• Supervise outside validation consultants and oversee equipment, facilities, utilities and software validation activities.
• Author and execute Process Validation protocol for new manufacturing process.
• Author, execute, review and approve Installation Qualification, Operational Qualification and Performance Qualification protocols including purified water systems (WFI), autoclave sterilization systems, freezer, refrigerator, class 100 and 10000 clean rooms, quality control instruments (BacT/Alert, Endosafe) and computer system validation.
• Develop Master Validation Plan for new manufacturing facility.
• Coordinate and provide technical support activities for the Manufacturing, Quality Control and Facility departments.
• Author, execute and review protocols for Media Simulation, Environment Qualification and Sterilization Validation.
• Verify and validate changes and improvements to current systems under Change Control system and decides on re-validation requirements.
• Oversee Calibration and Preventive Maintenance Program. Coordinate Calibration activities. Review and approve Calibration procedures, results and system re-evaluation according to schedules.
• Review and approve Standard Operating Procedures (SOPs), validations, batch records and other technical documents and records for accuracy, consistency and compliance with relevant requirements.
• Develop, apply and revise Quality Standards documents including SOPs, test methods, test procedures, work instructions, audit reports and investigations in compliance to applicable laws and standards.
• Participate in project meetings to ensure that current validation best practices and compliance expectations are integrated into written protocols by providing guidance on applicable regulations, internal policies.
• Troubleshoot issues that arise during execution of validation protocols by reviewing and approving root cause, deviation report, recommending corrective/preventive action.
• Work with Engineering, Manufacturing, Information Services and External Consultants to ensure QA Validation compliance for processes, equipment, utilities, process control systems, and quality systems.
• Monitor and track quality systems deviations and facilitate the implementation of corrective and preventive action (CAPA).
• Facilitate the establishment of product and material's specifications, process and product improvement in conjunction with Operations and Quality Control staff.
• Perform internal and external audits to GMP/GTP compliance, Quality Standards, company policies and procedures.
• Participate in cross-functional design, development, improvement and investigative activities. Capable of applying Quality Tools, such as FMEA (Failure Mode and Effect Analysis), HACCP (Hazard Analysis and Critical Control Point).
• Assist in the development, presentation and recording of training as needed.
• Facilitate and actively participate in third party and regulatory inspection activities.

Validation Specialist III Jan 2008 - Feb 2010
Confidential, Pearl River, NY Consultant March 2007-Jan 2008
Progressed from consultant to Validation Specialist III

• Authored, executed, Reviewed and approved Installation Qualification, Operational Qualification and Performance Qualification Protocols including water system (WFI), autoclave, computer system validation, SIP/CIP skids, aseptic filling line equipment, filter integrity tester, depyrogenation tunnel, washer, clean steam, compressed air, HVAC and filter validation.
• Overseen equipment, facilities, utilities and software validation activities.
• Quality review of Process Validation protocols which include Critical Process Parameters (CPP), Production Process Parameters, Hold Times, Performance Indicators, Batch Records, and Deviations for the production of new Serotype for Prevnar 13.
• Authored, executed, Reviewed and approved Cleaning Validation protocols for vaccine manufacturing equipment. These included product contact surface area, maximum allowable residue carryover, and rinsed water and swabbed acceptance criteria.
• Reviewed and approved summary reports for regulatory submission to FDA and EU for clean steam, autoclave and serotype manufacturing of new vaccine Prevnar 13.
• Participated in Change Control Review Board to verify changes and improvements to current systems.
• Worked on a team for new steris autoclave qualification and construction activities.
• Coordinated and provided technical support activities for the Manufacturing and Facility departments.
• Approved protocols for Media Simulation and Environment Qualification for Tandem drum filling process to fill two drums back to back which allowed reducing cycle time by 20%.
• Reviewed and approved Media Simulation, Cleaning Validation and Performance Qualification protocols for Product Transfer Skid (PTS) to download Polysaccharide from final fill tank to 250 L tank through sterile filtration and finally to 50L drums.
• Responsible for developing, reviewing and approving Standard Operating Procedures (SOPs), Calibration Procedures and Reports, Preventive Maintenance Orders (PMO's) and Work Orders utilizing Maximo software.
• Developed and implemented new HEPA Recertification Program which allowed reducing personnel cost for the company.
• Participated in project meetings to ensure that current validation best practices and compliance expectations are integrated into written protocols by providing guidance on applicable regulations, internal policies.
• Resolved issues that arise during execution of validation protocols by reviewing and approving root cause, deviation report, recommending corrective/preventive action.
• Worked with Technology, Engineering, Manufacturing, Information Services and external consultants to ensure validation compliance for processes, equipment, utilities, process control systems, and quality systems.
• Responsible for closing technology and maintenance related investigations in Trackwise and SAP CAPA.
• Reviewed and approved Quality Risk Assessment report for various Quality Systems utilizing Quality Risk Management Tools such as Failure Mode, Effects and Criticality Analysis (FMECA).
• Facilitated and actively participated in third party and regulatory inspection activities.
• Assisted junior staff to provide coaching and guidance on regulatory requirements during validation review.
• Adept at ensuring adherence to Quality Assurance standards, as well as meeting all project timelines and goals.

Confidential, Hawthorne, NY

• Reviewed and approved validation protocol final reports for water systems, processes, computer systems and cleaning processes to ensure protocols were properly executed and all deviations that occurred during the execution phase were resolved satisfactorily.
• Provided technical support activities for Manufacturing and other departments as required.
• Reviewed calibration procedures and results.
• Performed Quality audits to ensure cGMP compliance of packaging facility for contract manufacturers.
• Wrote and revised departmental Standard Operating Procedures and Test Procedures.
• Provided training for new employees.
• Applied to DEA for Import Declaration on continued basis, and overseen inventory maintenance of controlled substances.
• Overseen equipment, facilities, utilities and software validation activities

Validation Engineer (Consultant) March 2004 - April 2005
Confidential, Paterson, NJ

• Developed Process Validation and Cleaning Validation protocols for solid dosage form equipment.
• Authored and executed validation protocols for cGMP equipment including compression machine, blender, coater and utility systems including WFI.
• Investigated and resolved issues that arise during execution of validation protocols by writing deviation reports and recommending corrective and preventive actions to be included in final reports.
• Performed periodic reviews of equipment and utilities validation documents to ensure compliance with cGMPs and current regulatory requirements.

Programmer Analyst Sep 2002 - Feb 2004
Confidential, Iselin, NJ

• Worked on software life cycle from user requirements to design and implementation.
• Performed coding, debugging of computer programs using C++ and Javascript.
• Responsible for adhering to defined specifications and meeting project timelines.

Validation Supervisor Nov 1999 - March 2002
Confidential, India

• Supervised validation technicians and overseen equipment, facilities, utilities, processes and software validation activities.
• Authored, executed IQ/OQ/PQ protocols for various equipment including blender, coater, autoclave, washer, mixing vessel, filling machine, freezer and utilities including WFI, Compressed air, Clean Steam.
• Authored, executed process validation and cleaning validation protocols for blender, coater, filling machine.
• Performed shipping validation and container closure integrity validation.
• Reviewed and approved lab instruments validation documents including TOC analyzer, HPLC, Gas Chromatography and computer system validation documents including Building Management System (BMS).
• Implemented a validation strategy for process control systems to combine equipment, process and computer validation standards.

SKILLS

Trackwise, SAP, GxPharma, Maximo, MS Word, Excel, PowerPoint, MS Access, C, C++, JAVA, BPCS (Business Planning and Control System), WMS (Warehouse Management System), Lotus Notes.