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

• 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

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.
• 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

• 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.

• 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.
• 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.
• 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