Computer System and Validation Specialist
With more than 20 years of experience directing organization technology including full software development life cycle from conception through deployment of the validated  systems.. Blend of hands-on technical experience and management skills to lead and train team members in support of the business units.  Advanced communication skills make it possible to gather user requirements from clients in a painless and organized manor. CIO nominated to the FDA 21CFR Part 11 team (in Washington), holding a technical advisor roll with the FDA electronic submission system team. Successfully implemented and managed multiple change control systems, for the pharmaceutical and other compliant environments, resulting in passing both FDA and Sorbanes Oxley audits. Application expert successfully implemented more than 30 compliant systems including LIMS with both hardware and software configurations, validation, and backup and recovery. Computer Validation including User Requirements, IQ, OQ, PQ, URS and SDS documentation, Test Scripts and procedures of entire systems including Server, Client, and application. Perform 21 CFR Part 11, cGMP, cGXP, cGLP audits, risk assessment, traceability matrix, and remediation plans. Retro validation created for legacy systems or high rick systems, not in compliance. Corporate, divisional and site level SOP’s created or modified for compliance. Implementation and management of enterprise change control document systems. Test methods created including software unit, integration, functional, system, and acceptance testing. Advanced Laboratory system specialist including; the Electron Microscope (SEM), LIMS Labware, Beckman, Waters Millennium, Empower, and Empower2.

Rick Safford Online Resumes                            

CRM System Architect http://ricksafford.com
IT Manager http://richardsafford.com

Compliance http://ricksafford.com/Compliance_Resume
Document Management http://ricksafford.com/Document_Management

Link to Word Download Version of resume
Profile for
Richard Safford

Bushkill, Pennsylvania

Phone: 570-620-8810

E-mail: rick@ricksafford.com
 

·         Excellent Management skills, Experienced in leading off shore teams in development, business relationships fulfilling business needs and communicate clearly with management through reporting using oral and written presentations.

·         Expert in Documentation, Ability to lead, create, and implement needed SDLC documentation including URS, SDS, test procedures, full IQ, OQ, PQ, GMP, GXP, GLP, 21 CFR Part 11 compliance and validation, any needed documentation for FDA compliance.

·         Document Management Administrator
Managed,  implemented and trained multiple document management systems;
Qumas, Documentum, Eroom, cPDM, Lotus Notes
Managed Change Control system for entire division for Alpharma Animal Health

·         CRM Administration Experienced in all aspects of CRM, Architecture, Integrations, Server Administration, NT Active Directory Integration, Security, Managed Support Teams, Advanced Support Issue resolution and escalation process, Support including writing of support manuals for support team, training including online and in person training secessions, and vendor management.

·         IT Project management
a) CRM Enhancements (GE)
b) Documentation, SDLC, URS SDS (GE)
c) SalesLogix Upgrades (GE)
d) Knowledge Base (Sanofi Pasteur)
e) CRM Program and Support Manager (Panasonic)
f) Add Copier Division to CRM (Panasonic)
g) Add PIC Flat Screen Division to CRM (Panasonic)
h) Upgrade Camera and Television Division to CRM Saleslogix 7.2 (Panasonic)
I) Upgrade Toughbook Division to CRM Saleslogix 7.2  (Panasonic)
k) Create Patch Deployment System and Procedures (Johnson and Johnson)
j) Active Directory Upgrade (Alpharma)
k) Implement Microsoft Project Enterprise Edition along with Methodologies (Alpharma)
L) Implement SalesLogix CRM 4 Divisions
M) 21 CFR Part 11 Site Assessments and Laboratory Upgrades including 2 Waters Empower Networks (Alpharma)
N) Software Development built Analytical Standards Software for FDA compliance 
 

1.   Sales and marketing support:
Listed below are some examples of the latest CRM Enhancements.
a) Active support for Suspect Import of Marketing Data Imports, Data integrity and duplicate leads
b) Marketing has a need to update lead table to include additional qualification dates. (These changes are necessary for BI Marketing Report changes to occur, enabling marketing to better track leads and opportunities.
c) SLX Marketing has a need add a note in history with dependencies
d) Add additional selection menus to the lead status
e) Marketing has a need add a note in history with dependencies.
f) Marketing has a need to add values to the SLX campaign team selection menu to be in alignment with the new P&L structure and naming convention.
g) Active support for Suspect Import of Marketing Data Imports, Data integrity and duplicate leads

·         Application development and implementation

a) Managed an off shore team Birlasoft for GE Healthcare in development of 28 CRM enhancements many of these were marketing based. This included URS Requirements gathering, SDS, following SDLC documentation, code review, and standard development to production signoff.

b) Critical Job during the H1M1 Virus Outbreak Sanofi Pasteur was responsible for manufacturing Billions of doses of vaccinations. The facility was operating 24 hours a day and one of my responsibilities was to make sure any critical case were escalated, and resolved properly in a critical amount of time.
The process is extremely visible and Audited for FDA compliance.
At the Sanofi Pasteur facility, I supported over 200 different software applications, upgrades, deployment and Advanced Server and Network Management through.
   1) Network AD Account Creation (Validated Environment) and outgoing protocol and
       support.
   2) Outlook 2007 Mail Creation, OST, PST, Groups
   3) Documentum Management system 4 different Global Validated environments including
       user creation and outgoing protocol and support.
   4) TrackWise Study related data management 4 different Global Validated environments
       including user creation and outgoing protocol and support.
   5) Waters Millennium and Empower Laboratory system 8 different Global Validated
        environments including user creation and outgoing protocol and support
   6) Remedy Knowledge base creation to integrate with Remedy ticket system

  c)  Managed, developed, and deployed Analytical and Reference Standard software, for FDA
       Compliance.

GE Healthcare October 2010 – Present    Birlasoft (http://www.birlasoft.com). - Software Consulting Company

Title: System Architect     

Manage development of CRM and integration enhancements for business clients within GE Healthcare

Recent projects:

Responsibilities:
Managing enhancement development for SalesLogix CRM software, requested by multiple GE Healthcare Companies. Responsible for all daily interaction with requestors, managers, developers, and QC QA compliance to implement these changes within GE controlled environment. Successful in being able to define, refine, and implement changes requested by the business unit.
Duties include daily meetings with offshore developers, clients, GE management, program and design teams.GE project management trackers, quotes, time management, ITL case management through Peoplesoft CRM for development and HP Quality center is used to manage defects, and software release cycle procedures.

Sanofi Pasteur 6/2009 to 10/2010

Title: Security Administrator (ASM Team) 7/2010 to 10/2010

Description: Part of an elite team that manages all Network accounts, software applications, folder security, and email creation. Main objectives are account creation, granting access, following ISP’s, policies and procedures for compliance and adherence.

Title:  Support Analyst 6/2009 to 7/2010
Support for all Sanofi Pasture User Computers, Applications and Servers in North America and Canada.

Responsibilities
Applications supported SAP, SAS, SAP CRM, Remedy, VPN, Beckman LIMS, Alteris, eRoom, Documentum, Microsoft Project, SQL and over 200 different software applications.  Defines and prioritize, refer, track, and escalate End-User problems in accordance with Service Level Agreements. Use automated tools to route, monitor, and track End-User call ticket ownership through closure. Duties include Active Directory, Global Policy management, including server and client security. Main achievement was an advisor, editor, and developer in the creation of the IS knowledge base application.

Panasonic 11/2007 to 3/15/2009 Global 100 Corporation
Title: CRM Program and Support Manager

SalesLogix support for five different companies, along with managing, training a support helpdesk, and three other advanced SalesLogix technical service personnel. Responsible for all aspects of the CRM process, including daily interaction with Sage and primary Sage Partner, and IBM support to manage projects, which also included monitoring technical billing. Responsibility includes end user support, which required, employing advanced troubleshooting skills to keep the system, reliable, accurate, and stable. Third party software Knowledge Sync support includes daily monitoring, support, development, and maintenance.

Responsibilities

• Servers: 15 SalesLogix Servers: Seven Sync Servers, 4 Application Servers, 4 Database servers, responsible for Day to Day processes, Monitoring, and performance.

• Applications: SalesLogix Administrator Module, Scribe, Architect, Sync, Microsoft SQL 2003 and 2005, Oracle 10g, SQL Express, MSDE, Microsoft Outlook all versions, Lotus Notes 6 and 7, Crystal Reports 

• Third Party Software  Knowledge Sync, Scribe, LinkPoint, IntelliSync, Click View,

• Responsible for company and client end-user computing and technical devices ∙Support remote users  ∙Accountability for all IT related activities in order to ensure efficient use of internal and external resources for company and clients ∙Ensure support and resolution in accordance with approved service level agreements (SLA) ∙Provide weekly problem and service metrics for management review ∙Develop and support and end-user support strategy that will scale with company growth and client expectations ∙Perform support cost analysis and seek lower cost support solutions ∙Leverage experience, staff and vendors to minimize system downtime and exceed client expectations ∙Manage 3rd party vendors ∙Data back-up protocols and maintenance ∙Server application support for company and clients ∙IT security monitoring and controls ∙Day to day management of help desk: onsite and remote support ∙PC user hardware ∙PC user software ∙Integration of software/hardware solutions

• Knowledge requirements: LAN, WAN ∙Lotus Notes ∙SalesLogix ∙Database/database management ∙CRM software ∙Software: MS Excel MS Project, MS Outlook, Windows XP, Windows 2000, Windows NT ∙Hardware: Blackberries & other PDAs, desktops, laptops, printers ∙Antivirus ∙FTP ∙Database ∙SQL & Oracle database work ∙PC desktop administration ∙Technical documentation

• Skill Requirements: Focus on serving internal and external customers ∙Strong project management skills ∙Business acumen and interpersonal savvy ∙Process and project management ∙Excellent written and verbal communication skills ∙Strong bias toward action and resolution ∙ acuity and tenacity to quickly develop user friendly solutions ∙Ability to manage projects from conception through closure ∙Limited need for supervision or assistance ∙Comfortable and credible in client-facing role ∙Experience managing small staff and/or vendors ∙Rapid diagnostic and problem solving

JOHNSON & JOHNSON (CORDIS) NJ 5/2006 to 11/2007 Fortune 500 Company.
Title: Laboratory and Business Systems Support Lead

Advanced laboratory support, which included support, maintenance, and administration of all validated laboratory systems at the Cordis Warren NJ facility. Developed and implemented a Patch deployment system working directly with Microsoft, IBM, and individual vendors to assess, test and deploy needed Microsoft, Oracle, Virus, and security patches to validated systems. Support for all systems, QA, QC, R&D and Engineering. Managed Change control processes for validated all laboratory systems.

Responsibilities

• Managed change control for validated laboratory systems
• Patch deployment, research, vendor approval, testing and release to production.
• Weekly meetings on status relating to patching.
• Chromatography data networks Management, including Waters Millennium, Empower, Empower2, and latest implementation of Waters Acquity system. All Empower servers, clients, communications, troubleshooting, and installs for the HPLC software.
• Maintaining Blue Hill testing software for R&D laboratory.
• Maintaining Windream Software with Leo EVO60 Scanning Electron Microscope (SEM).
• Maintenance monitoring and modifications of Compliance Builder system.
• Autocad Enterprise deployment support for engineering and research

  NETWORK SOLUTION 8/2005 – 5/2006
Title: Technical Service Specialist
Duties included domain registration, technical trouble shooting of all clients’ websites and web based applications.
Responsibilities

• Domain Registration
• Advanced DNS Trouble shooting
• Email support for all email clients, Outlook, Notes, Eldora, and Network Solutions web based clients.
• Advanced database support (all databases)
• Advanced script support for Microsoft languages ASP, ASPX, .NET
• Multiple language support, C, C#, VB, VB.NET, ASP, CGI, Pearl, PHP, HTML,XML

ALPHARMA INC 8/2000 – 3/2006 Animal Health Division
Title: Data Program Manager

Managed all activities related to the effective development, management, and support of the company's network and computerized systems. Implemented Active Directory for 15 NT.40 Servers to Windows 2003 Servers. Responsibilities included ensuring   FDA and Sarbanes-Oxley compliance and direct oversight of applications, databases, e-mail, web, Intranet, server, LANs, WANs, connectivity, disaster recovery, testing, and lab systems. Managed the curriculum courses for compliance to meet FDA, and SOX requirements.

Responsibilities

• SalesLogix Experience: Original CRM was a custom-built system with very high development costs and even higher maintenance costs. Overall expenditure for system was 750,000 per year. The system used local Microsoft access databases for local client versions. The system had no easy way of synchronizing data to one central database. Access databases were sent email to system administrator, then in a non-automated procedure one at a time imported into SQL database. After all data was updated in SQL database, access databases were exported out of SQL database and then email to the clients. Managed the largest implementation of SalesLogix, which grew to thousands globally. 
• SalesLogix implementation all servers and clients.
• Applications: SalesLogix Administrator Module, Scribe, Architect, Sync, Microsoft SQL 2003, SQL Express, MSDE, Lotus Notes, Crystal Reports.
• Project Management: Microsoft Project Enterprise Edition including SharePoint and SQL Servers.
• Active Directory rollout for Alpharma by converting 15 NT.40 Servers to Active Directory (Windows 2003) this includes creation of hundreds of groups, application, application testing, application migration, user migration, Advanced DHCP and DNS modifications to meet full network compliance.
• Document Management: Qumas, Documentum, Oracle and SQL Database Environnements
• HPLC Laboratory Systems: Shamatsu, Waters Millennium, Waters Empower, Waters Empower 2, Oracle Database Environments (These are full networks in multiple types of Laboratories, Including QA, QC, R&D, and Analytical)
• Led Alpharma Site assessments and remediation of US production sites 2002 -2005.
• Successfully passed numerous FDA and Sarbanes-Oxley audits by ensuring that all company systems, processes, policies, and procedures met all compliance and regulatory requirements.
• Authored and executed of over 40 SOP’s and needed validation documentation for compliance.
• Alpharma FDA Approval with Lasalosid Sodium in Willow Island WV
• Alpharma FDA Approval with Deccoxin Chicago Heights IL
• Led training all 21 CFR Part 11, GMP, GLP, and GXP systems.
• Custom Built Software Analytical and Reference Standards, Customer Service Complaint system, Audit System, Regulatory Project tracking system, Sale Query: system pulls data from JDE, KPI System (Key Productivity Indicator} all division 1,200 users, Alpharma Internets Global http://www.alpharma.com, Alpharma intranet Global

AMANO CINCINNATI 10/1998 – 8/2000 Time and Attendance Company
Title: Webmaster
Web development, construction of new website and online advertising campaigns including Yahoo, Excite, and MSN. CRM software implemented: Goldmine and ACT.
Responsibilities

• Managed all Web development http://www.amano.com 
• Led Marketing Campaigns with Yahoo, MSN, Excite
• Manage ACT CRM system to import Dunn & Bradstreet leads mailing utilized  Amano’s customer database to e-mail or fax potential customers
• Led Goldmine CRM enterprise edition project for managing Amano customers in one central location.
• Database development

EDUCATION
[2007] Belford University, BS Computer Science                                Humble, TX
[1978} Western Connecticut State University, BS Music Ed