SUMMARY:

• Over 20 years experience in the Clinical, Pharmaceutical, Bio - tech, Medical Device, Food and IT industries.
• Strong ability to effectively communicate across all organizational levels in order to achieve program outcomes.
• Broad industry perspective and a clear understanding of processes, methodologies, and tools.
• Engage large or small initiatives with regulatory driven approaches, methodologies and processes

TECHNICAL SKILLS:

Clinical Trials: Confidential, Hospira, Confidential, Confidential, Omnicare, Confidential, etc.

Biotechnology: Astellas, Confidential, Confidential, etc.

Medical Device: Confidential, Confidential, Depuy Synthes, Confidential, etc.

GLP Animal studies: Confidential, etc

Quality Management System: JNJ, Astra Zeneca, Confidential, Shin Nippon Biomedical, etc.

IT, CSV and Validation: Wipro, Novartis, Confidential, Confidential, Alcon, Confidential, Lannett, etc

Manufacturing: DCS, MES, SCADA, BMS, ERP

PROFESSIONAL EXPERIENCE:

Confidential

CSV Lead

Responsibilities:

• Responsible for managing CSV efforts for a team of analysts, developers, testers and engineers to drive delivery of (ITSM) SIAM (Service Integration & Management Delivery) GXP processes for Change, Event, Problem, Incident, Configuration, Deployment, Release, Validation and Testing, etc. Twenty-one IT service Management process areas were integrated in seventeen functional business units. I served as a CSV specialist with expertise across all tracks. I developed methodology, approach and templates for executing Risk Assessment, V-plan, Infrastructure Qualification, Testing, and Data Migration utilizing as well as traceability, and document control via Quality Center and Master Control.

Confidential

Sr. QA lead

Responsibilities:

• Work on special projects for a New Startup: Manage CAPA generation and implementation for facilities utilities and equipment. Work with the plant management to whip new processes into place, redefine batch reports and Investigate discrepancies, etc. Report to the Director of Quality. Authored SOPs for the PM and operation of steam system and new equipment/parts for various facilities.

Confidential

Sr. Project Manager

Responsibilities:

• I authored validation protocols, Studies, and procedures as well as trained and walked personnel through the process, conducted Risk Assessments, determined cleaning agents, defined automated vs manual cleaning, managed operators and technicians wrote communications, released equipment, determined hold times (dirty/clean/sanitized), and conduct various studies on the ability of the environment to keep equipment clean, collected swabs and determine sampling locations for TOC and detergent residues for equipment like the Korsch, Tarceva, Fetti and Courty press, Bohle, etc.

Confidential

Quality System Expert

Responsibilities:

• Developed a set of Global Quality analytics (Metrics, KPI's, Dashboards, Scorecards, Wireframes) for the CAPA and Deviation process to be included in the APR. Structured workshop activities and responded to the RFP's
• PMO SME Manager for Utilities, facilities and Equipment.
• Adopted the worst case project and finished ahead of the other project managers in the work stream.
• Developed and executed assessments for European and U.S.A manufacturing sites for compressed gas and preventive maintenance program.
• Executed ISO assessments for Controlled Environment Areas CERs and Clean Rooms (Compressed Gas, HVAC, Environmental Monitoring, PMs, Hydrocarbons,, Procedures, Vendor Management, etc .
• Performed Audit Remediation and CAPA root cause and corrective / preventive action as necessary. Performed CAPA verification of effectiveness as necessary.
• Held daily meetings and travel to Legacy Synthes sites and provide assessments.
• Provided consultancy and guidance related to Facilities and Equipment Controls and Legacy System.

Confidential

(SME) Cleaning Validation

Responsibilities:

• Wrote and managed execution of cleaning validation, protocols, analyzed microbiological, visual, analytical and physical data to detect trends and develop corrective actions as necessary.
• Wrote validation reports to summarize results and findings.
• Reviewed and analyzed cleaning run records, detected negative trends and non-conformances, and developed and implemented process improvements as needed.
• Mentored and provided guidance for QA manufacturing batch record documentation for accuracy, completeness and compliance with effective SOPs to ensure the strength, identity, safety, purity and quality of the product.
• Completed walk downs to ensure adherence to GXPs.

Confidential

(SME) CSV Subject Matter Expert

Responsibilities:

• Developed the methodology and procedures for CSV system use / operation, data backup and restore periodic review, change management, problem reporting, archive and retrieval, performance monitoring, preventive maintenance, startup and shutdown, configuration management, records retention, security/system administration, and business continuity for manufacturing and laboratory systems.

Confidential

Sr. QA CD GMP Specialist

Responsibilities:

• Worked with quality work stream leads. Participated in FDA audits, .investigations and walk downs (ETQ and TrackWise)
• Facilities/utilities/Equipment (Compressed Gases, HVAC, Pest Control, Purified Water System, Calibration, Commissioning and Qualification, Cleaning & Sanitization, Maintenance, Security Controls, Infrastructure).
• Validation (Computerized system Validation CSV, Cleaning validation, product, Process, CSV/electronic records-electronic signature processes, GMP Spreadsheet Remediation, Computer Systems and Applications, Packaging, Process validation, Laboratory systems, Manufacturing systems, etc).

Confidential

IT GMP Cloud Expert

Responsibilities:

• Developed a GMP Cloud System to serve Pharmaceutical, Medical Device, Bio-pharmaceuticals, etc, by integrating 21 CFR part 11, 820 Quality System, and ICH Quality Management and more.

Confidential

Project Manager Senior Clinical Investigator

Responsibilities:

• Managed a team of six investigators at Hospira to write Quality Investigations for deviations on the client's Quality System in TrackWise.

Confidential

Senior Project Manager IT/ QA Clinical Validation

Responsibilities:

• Managed remediation effort CSV in Toxicology, Carcinogenicity, Developmental & Reproductive Toxicology Immunotoxicology, etc.

Confidential

Sr. Auditor

Responsibilities:

• Audited four hospitals in Eastern Africa for clinical and operational compliance: Sodo Hospital (Ethiopia), Kijabe Hospital (Kenya), MCM Hospital (Kenya), Tenwek Hospital (Kenya).

Confidential

Project Manager

Responsibilities:

• Reported to the CIO Develop Process Maps, Narratives and Efficiencies for an SAP implementation into their Quality System, specifically the manufacturing process.

Confidential

Sr. Validation Manufacturing Execution System (MES) WonderWare

Responsibilities:

• Contact Lens manufacturing Upgrade of the MES system to become compliant with the most recent Novartis standards (Windows Server 2003 SP2 and Oracle 10g) and address compliance gaps.
• Moved equipment and processes to India.

Confidential

Clinical System Project Manager

Responsibilities:

• Managed 16 resources on/offshore resources Manage cost, schedule, and performance of component projects for the Wyeth/ Confidential merger for merging post marketing commitments (PMC), (CMC) commitments, mutual recognition program (MRP), EU centralized approval process (CAP), de-centralized (DCP), nationals (specific to a board of health), investigational new drug annual reports (INDAR) and CTSUR master schedule, agency meeting, EU end of trial notifications, pediatric investigation plans, into one computer reporting system.
• Develop protocol, generate the required documented evidence to support the (IOPQ) effort of the GMC TrackWise system. Merged multiple instance of TrackWise between Confidential and Wyeth respectively TrackWise (4.8, 5.9 and 6.0)

Confidential

Laboratory Program Manager

Responsibilities:

• Laboratories included: Raritan NJ, Radnor PA, Springhouse PA, Malvern PA. Managing multiple, complex projects and managing the programs budget, validation strategies and project delivery teams.

Confidential

Global Clinical Operations Clinical Trials Change Management for Documentum

Responsibilities:

• Managed the Change Control and CAPA process and validation process for Clinical Trial changes, for help desk (T1, T2 and T3), R&D Applications Group and ITS (Information technology Services) to resolve past and future issues,( Belgium, India, USA)

Confidential

(GRC) Methodology Lead

Responsibilities:

• Integrated (24) major computerized systems (TrackWise, etc,.)
• Wrote the Verification Strategy for the project.
• Incorporated governance surrounding Oracle’s (R12) application Oracle E-Business Suite and Oracle AIA and Fusion Middleware

Confidential

Quality Medical Device Project Validation Manager

Responsibilities:

• Managed five sites utilizing over a half million dollars a month.
• Managed the process and product validation of metal and polymer ligation systems, surgical appliers, external skin-stapling devices, polypropylene suture Systems, Needles, Valves, etc.
• Managed production activities and developed design files as well as validation requirements.

Confidential

Sr. Software Quality Project Manager Validation

Responsibilities:

• Conducted various GXP, Risk, and technology assessments. Managed the full lifecycle validation of J.D. Edwards EnterpriseOne and Agile PLM

Confidential

Sr. Project Validation Manager IT-QA

Responsibilities:

• Coordinated development of software validation activities for Confidential ’s medical devices in Europe and the US
• Directed site leaders towards developing; authoring and reviewing and ensuring that all validation activities adhere to global standard processes

Confidential

QA Procedural Process Control Validation Engineer

Responsibilities:

• Wrote for, Confidential ’s management plans Software Quality Assurance Plan (SQAP), Global Software Configuration Management Plan (SCMP), and their Package Configuration Specification (PCS) to procure a contract with Confidential to support manufacturing operations.

Confidential

Project Management for QA Clinical Validations

Responsibilities:

• Wrote the development of Validation and Quality Project Plan, Functional Specification, Design Specification, Test Protocols Qualifications, verification of (IQ, OQ, PQ) and more.

Confidential

Medical Device Process Quality Validation Engineer

Responsibilities:

• Developed, designed and executed protocol for IQ, OQ, Process Q, PPQ (Process and Product), PV, MVP, MVR, design experiments, etc. Develop AQL, Sampling plans, LTPD, Normality, statistically define the process. Process diagrams

Confidential

Quality Project Manager

Responsibilities:

• Validated The Foxboro (DCS) control system and developed documentation for the Project Initiation Phase, Requirements Phase, Design Phase, Implementation Phase, Installation and Test Phase, Operation and Support Phase for over forty systems

Confidential

Global Remediation Technical Lead Computerized Systems

Responsibilities:

• Remediated laboratory automation equipment that was used to analyze approximately 10,000 samples a day for 120 instruments in 1/3 of the time of other divisions and help prepare the Indianapolis location for an FDA audit

Confidential

QA Validation Consultant

Responsibilities:

• Became a source of project management, computer validation, software testing, and systems documentation services experience to Pharmaceutical companies.

Confidential

Sr. Quality Assurance/Scientist

Responsibilities:

• Oversaw quality operations for research, manufacturing, clinical packaging, environmental testing, shipping, labeling, Reviewed Batch records, finished products, in-process results, API’s records, Audited manufacturing and laboratories, trained employees and conduced investigations.

Confidential

Sr. QA Compliance Specialist

Responsibilities:

• Provided clinical trials management (Phases I-IV), data analysis and data submission in all major therapeutic categories for the pharmaceutical manufacturers and biotechnology companies. Reviewed/approved all assigned R&D reports, investigations, change controls, calibration records, SOPs, method development, method validation, and stability

Confidential

Senior Research Compliance Specialist/ Auditor

Responsibilities:

• Supported manufacturing, packaging, in releasing products and services. Conducted periodic audits of all facility laboratories, reviewed IND’s, NDA’s, CMC, FDA responses, Stability, Instrument Calibration, Laboratory Investigations, etc.,

Confidential

QC Chemist/Compliance Auditor

Responsibilities:

• Investigated consumer complaints surrounding Advil, Chapstick, Preparation-H, Centrum, Robitussin, Caltrate, Pregnancy Sticks, Today’s Sponge and more. Audited notebooks for over fifty-two chemist

Confidential

Pharmaceutical Development Chemist

Responsibilities:

• Maintained the integrity of instrumentation in the laboratory. Conducted method development, purity, cleaning validation, process validation, assays, content and dosage uniformity etc.

Confidential

Pharmaceutical Chemist

Responsibilities:

• Responsible for wet chemical analysis on Anionic and Cationic exchange resins, acid base reactions, discolorations, UV analysis, Separation.