senior technical lead Resume

SUMMARY:

9+ years’ experience of implementation and support of EQMS TrackWise for food, pharma, medical device and biotech firms. Types of projects implemented include Complaints, Deviations, Adverse Events, Quality Investigations, Change Management, CAPA, Document Control, and Audit Management. Audit Management experience includes full Audit Execution Package configuration.
My professional mission is to provide my customers with the best possible solutions to define, manage, track, and report on activities for their core business functions.

PROFESSIONAL EXPERIENCE: senior technical lead

Confidential

Customer facing liaison and technical lead for company at large pharmaceutical manufacturing division.
Designated on - site TrackWise configuration (version 8.5.1) and Crystal Reports 2008 development subject matter expert.
Complied with company’s SDLC standard of implementation of technologies
Upgraded two separate older instances of TrackWise from versions 6.x and 7.x to version 8.4.5.
Led requirement gathering workshops for new instance of TrackWise which included record types of Inspection, Audits, and Observations. Scope included Audit Execution Package requirements as well.
Authored a Functional Requirement Specification document for final business approval.
Configured requirements for the above mentioned records into TrackWise in addition to the Audit Execution Package (AEP) portion as well as offline ConfigForms.
Developed test cases against the Functional Requirements Spec to test system readiness during validation and assisted with execution of scripts when appropriate.
Developed Crystal Reports required by the business for metrics.
Provided time estimates for Statements of Work inclusion for all activities including configuration, documentation, testing, validation, and promotion to production.
Maintained concise documentation on everyday activities, as well as longer term activities to ensure adherence to the project plan, and to provide a central location tracker for all team members

solutions delivery consultant ii

Confidential

Responsible for implementing TrackWise configuration projects at customer sites, acting as the single point of contact for customers.
Main duties included, gathering requirements, documentation, configuration, and deployment.
Leveraged an out-of-the-box (preconfigured) TrackWise Solution to meet Deviation, CAPA, and Audit Execution Package requirements for a large Clinical Research Organization.
Managed a large data migration with the use of PR Import.
Administered TrackWise Boot Camp, an intense two-week training to international partners of Confidential Inc. in Shenzhen, China.
Provided clients with Crystal Report solutions to meet business needs for tracking and trending.
Mentored, guided and trained new-hires to effectively perform duties, manage customer expectations, and overall management of life/work travel/home balance.

CUSTOMER SUPPORT REPRESENTATIVE

Confidential

Provided phone support for flagship software to pharmaceutical sales reps
Gathered requirements for customization enhancements for software used to track sampling and signatures of doctors.
Assisted with ensuring completion of the SDLC process