We provide IT Staff Augmentation Services!

Technical Manager Resume

EXECUTIVE SUMMARY:

  • 20 years validation experience
  • 12 Years TrackWise experience
  • Upgraded TrackWise to version 8.2
  • Designed, developed and validated multiple TrackWise Systems
  • Highly Proficient in Crystal Reports
  • Project Managed the design, validation and implementation of Blue Mountains Regulatory Asset Manager
  • Represented Fort Dodge Animal Health in an industrial panel meeting with the FDA (CVM) to implement and codify electronic submissions under 21CFR Part 11
  • Managed the on - site validation of SAP bar-coding systems in France and Ireland

JOB EXPERIENCE:

Confidential

Technical Manager

Responsibilities:

  • Manager of a ten-person team including on-shore and off-shore resources
  • Manage 24/7 support of a Global TrackWise environment that oversees 350 help desk tickets
  • Manager of a ten-person team including on-shore and off-shore resources
  • Manage 24/7 support of a Global TrackWise environment that oversees 350 Monthly Help Desk tickets
  • Manage the Service Now Portal for Quality, that includes Change Control, Incident ManagementKnowledge Base Articles and Problem Management
  • Prepare Monthly Metrics and Ad-Hoc Metrics

Confidential

Lead Consultant

Responsibilities:

  • Maintained two TrackWise environments one for South America the other for EMEA
  • Wrote 20 Knowledge Transfer documents to train off-shore resources
  • Perform Data Imports, Migrations and PR Imports
  • Develop and update Crystal Reports
  • Interact with DBA’s and Windows team to find root cause issue
  • Create validation protocols for new functionality

Confidential

TrackWise/Validation Consultant

Responsibilities:

  • Project Manager for an upgrade to an existing instance including custom reports, configuration changes and coordinator updated

Confidential

Business Analyst - TrackWise Specialist

Responsibilities:

  • Administration, configuration, and maintained TrackWise
  • Created Custom Report using Crystal Reports
  • Supervised TrackWise upgrade to version 8.2
  • Project Managed and Validated Blue Mountain Regulatory Asset Manager
  • Managed, Configured and Validated HP Quality Center for an Oracle R12 upgrade
  • Reviewed and investigated IT related Non-Conformance Reports

Confidential

Quality System Engineer

Responsibilities:

  • Administration, configuration, and maintained TrackWise
  • Responsible for documenting user requirements, converting requirements to functional specifications and implementation of the specifications in the TrackWise system
  • Act as liaison between the Quality Systems and users to define and implement user requirements for applications
  • Provide status reports to management detailing timelines, s

Confidential

Validation Consultant

Responsibilities:

  • Created and revived Hardware and Software protocols
  • Created and revived protocols for IQ, OQ and PQ
  • Ensured compliance with PDMA regulations 21CFR Part 203 and 21CFR part 11

Confidential

Manager, Information Management Quality Assurance

Responsibilities:

  • Performed quality audits of computer validation for Clinical and Non-Clinical systems
  • Validated and managed computer systems within 21CFR Part 11 regulations and 21 CFR Parts 210 & 211
  • Maintained the validation state of the worldwide instance of SAP R/3 4.6c and Bar Coding systems
  • Managed the change control process for global computer systems
  • Directed and audited the global validation of the SAP R/3 upgrade
  • Reviewed, managed and audited validation efforts for other divisions of BMS including LIMS and customer complaint programs
  • Managed and supervised a staff of consultants and internal project teams
  • Managed, reviewed and audited data conversion protocols and procedures for legacy AS/400 systems
  • Served on a committee to update and modify fundamental BMS policies and SOP’s regarding computer validation compliance related to FDA and global regulatory concerns

Confidential

Quality Assurance Senior Associate

Responsibilities:

  • Conducted Vendor Audited and internal audits according to PDA & FDA guidelines
  • Validated, managed and reviewed computer system for 21 CFR Part 11 compliance and 21 CFR Parts 210 & 211
  • Reviewed and audited validation of Oracle Clinical in relation to GCP regulations
  • Managed the change control process for Knoll’s SAP instance
  • Reviewed and approved validation plans, test protocols and performance qualification documents for a variety of computerized systems
  • Created, reviewed, and modified standard operating procedure related to quality audits and computer validation.
  • Maintained the validation efforts at a CGMP manufacturing facility, which included inventory control, evaluation and classification of systems

Confidential

Electronic Records Administrator

Responsibilities:

  • Corporate liaison for the FDA/CVM (Center for Veterinary Medicine), regarding new regulations for 21 CFR Part 11 compliant electronic submissions
  • Initiated and maintained open communications with other divisions regarding electronic submissions and electronic records management
  • Established, reviewed, communicated, and implemented policies and procedures for electronic records
  • Managed optical scanning and electronic storage and retrieval of Records Management and Archive files
  • Provided document retrieval and general support, as required, during inspections by regulatory agencies

Confidential

Validation Consultant

Responsibilities:

  • Participated in the development, implementation and rollout of a Beckman 8.4a LIMS System
  • Conducted the validation of client/server hardware and software
  • Wrote the acceptance test, validation protocols, and manuals
  • Developed a long-term project plan, including the testing of software to track and maintain change controls for this product in order to have an audit trail of its developments

Hire Now