Robert Walker Email & Phone Number

• Provide IT Quality Management and Validation services to the Pharmaceutical and Biotech industry including: • Authoring Validation and Quality Plans and Reports • Authoring System Classification Documents and Risk Assessments • Review, and approve qualification protocols and reports • Review, and approve System Life Cycle Documents including, User Requirements, Functional Risk Assessments, Traceability Matrixes, Training Materials • Liaison with other project/department Quality Managers to ensure project deliverables met project requirements

Nantes, Pays De La Loire, Fr

• Provide Project Quality Management services for Experis IT clients• Responsible for document number and tracking• Author Validation and Quality Plans and Reports• Author a Site Deployment Plan and Acceptance Reports for deploying the application to Global Sites• Assist in authoring System Classification Documents and Risk Assessments• Review, and approve qualification protocols and reports• Review, and approve System Life Cycle Documents including, User Requirements, Functional Risk Assessments, Traceability Matrixes, Training Materials• Liaison with Pharma ERP Quality Manager to ensure project deliverables met project requirements

• Provide Quality Management services to Elan clients• Responsible to oversee Vendor Quality and Compliance for a Novartis vendor hosting a BMS Remedy system with approximately 110,000 users.• Responsible to oversee Vendor Quality and Compliance for a client vendor providing Hosting Services• Responsible to oversee Vendor Quality and Compliance for a client vendors providing Service Desk services in Europe, Asia and North America• Responsible to oversee Vendor Quality and Compliance for a client vendor providing Managed Print Services to Novartis in Europe, North America, and Asia• Review, and approve qualification and validation plans, protocols and reports for vendor services delivered to client• Liaison with the client Operational Quality Manager to ensure Client – Vendor process continuity• Support vendor audits

South San Francisco, Ca, Us

• Manage Computer System Validation activities for the IT Department. Systems include Livelink ECM (Electronic Content Management) System, eCTD (electronic Common Technical Document) Publishing System, Statistical Computing Environment (statistical program management) System, and HPLC Data Collection and Processing (Empower) System• Liaison with the Quality Assurance Department for new projects and Change Management• Write, review, and approve validation plans, protocols and reports• Initiate IT Best Practices (Standard Operating Procedures) for all of the IT supported systems• Assist Quality Assurance with FDA audits and responses• Present and defend IT processes to Financial Auditors for Sarbanes-Oxley (SOX) 404 compliance• Represent validation on all IT project teams• Supervise contract personnel for conducting validation and SOX compliance activities• Support help desk for both Regulatory and SOX requirements

• Manage all validation activities for Process and Project Engineering Department. Validation activities include Computer System Validation, Facility, Utility, and Equipment Validation, Process and Cleaning Validation• Review, and approve validation plans, protocols and reports• Initiate Good Engineering Practices with the engineering group for commissioning, qualification, and validation activities• Assist Quality Assurance with FDA and outside audits• Manage a staff of three people and supervise contract personnel for conducting validation activities

• Validation and regulatory consulting for the Pharmaceutical, Biotechnology and Medical Devices Industries• Preparation and technical review of validation plans and facility startup plans• Preparation and technical review of validation protocols and reports• Onsite staff augmentation in Validation for facilities, utilities, equipment, and process control systems• Onsite staff augmentation in Quality Assurance for 21 CFR Part 11 compliance (Electronic Records/Signatures)• Manage qualification and validation projects for database and enterprise systems e.g. Document Management Systems (DMS) with biometric electronic signature, Laboratory Information Management Systems (LIMS), Corrective and Preventative Action Systems (CAPA), Discrepancy Tracking System, SAP, Oracle• Manage qualification and validation projects for Distributed Control Systems e.g. Delta V, ABB MOD 300, Intellution FIX32• Manage qualification and validation projects for process equipment e.g. Fluid bed granulators, sieves, extruders, tablet presses, pan coaters, fermentation vessels, UFDF skids, chromatography skids, viral inactivation tanks, labelers, fillers, cappers

• Responsible for the implementation of a LIMS for the Quality Control Therapeutics and the Quality Assurance Environmental groups. The system captured test results and generated reports for products and facilities in Emeryville, CA; Vacaville, CA; St Louis, MO; Puerto Rico and Amsterdam• Worked on a project team with three managers and supervised a team of three people

• Preparation and execution of protocols for validation of a LIMS• Preparation and execution of protocols for process equipment• Establish equipment acceptance criteria based on process requirements• Onsite support for Puerto Rico and Spain manufacturing sites in debugging and validating new facilities, equipment and processes used to manufacture solid dose prescription and over-the-counter drugs 90% from April of 1993 to July of 1994• Provide technical justification for process equipment cleaning program

• Project management and engineering design services to the medical, biotech, and pharmaceutical instrument industries• Together with a business partner, responsible for all business and technical decisions

• Responsible for design and development of large scale hollow fiber mammalian cell culture system used for the production of large quantities of cell derived proteins• Lead a six person design group• Establish design standards and initiate a document control system• Responsible for material selection for biocompatibility and maintaining sterile system operation

• Primary engineering interface to a contract engineering firm for the design and first customer deliveries of a clinical protein analyzer• Support first customer shipments and field support for three months

• Responsible for the electrical and mechanical design and development of equipment used for mammalian cell culture; received two patients for the design work• Initiate a documentation control system• Assist in the start up of equipment manufacturing• Customer support and assist in setting up an office in Japan

• Responsible, at various times, for the design, build, test, and implementation of control software for equipment used to test components and modules used in the manufacture of mainframe computer systems