Management Project

RESUME

Luis A. Jiménez Silva Urb. Villa Turabo, D6, Cipres Street.

Tel. (787) - 653-6759 Home or Mobile 787-***-**** Caguas, P.R. 00725

E-Mail: ***************@*****.*** Available to Re-localization

OBJECTIVE:

I am seeking a challenging and opportunity position in Quality System Management or Labware LIMS Administrator. My background is in Biopharmaceutical industry.

EMPLOYMENT HISTORY:

WYETH / PFIZER PHARMACEUTICAL, Guayama and Carolina Sites P.R. April 2002 to October 2012.

(Site in Closing Transition)

Position: Labware LIMS (Quality System – Administrator)

- Support Information to Management and Users in the organization on how to use various types of software efficiently and effectively

in fulfilling business objectives. This includes Labware LIMS, Empower CDAS and SAP Quality Module. Primary responsibilities

include Project Management, Change Management, Validation Requirements, Revision, Upgrade, New Release, Improvement,

Maintenance and Enhancement the Quality System Operations.

- Labware LIMS Implementation establishes the Business Rules and Validation Requirements for Labware LIMS Application. In this

application evaluate strategy of Business Requirements for Validation System. Coordinate the activities of team members and create

the following documents in order to define validation requirements as: Workflow As Is, Workflow To Be, Technical Design, SCO

Change Control, Project Plan, Validation Plan, Training Plan, SOP Plan, Impact Assessment, Traceability Matrix, Master Data Load,

Validation Summary, IQ-OQ-PQ Summary, Master Data Summary and Test Script Executions.

- Labware LIMS Deployment experiences in coordination and deployment for Master Data Team Build Objects, Standard &Reagents,

Instruments, Chemical and Microbiology Analysis, Product Specification, Environmental Monitor Water, Environmental Air &

Surface, Explore Table, Menu and Toolbar, Labels, Reports, Cleaning and Validation Samples and finally data migration from

Development environment to QA environment and then to Production environment.

- Labware LIMS Configuration configure and provide Functional Requirements of Table Master and Build Objects Configuration

for Standard & Reagents, Labels, Reports, Analysis and Product Specification that were applicable to following link build objects:

Access Routine, Query Tag, Store Query, Analysis Rules, Test List, List, Subroutine, Process Stage, Process Equipment, Location,

EM Tables, Common Name, Folder Template, Lot Template, Project Template, Protocol Template, Parsing Script, Approval Role,

Approval Routing, Time Point, User, Worklist Link, Worklist Protocol, Worklist Template, Worksheet Template, QC Sample,

Inventory Location, Format Calculation, Analysis Type, Ad Hoc Component, Condition, Investigation Template, Units, Events,

ID_ Configuration, Product, Analysis, Instrument Template and other tables.

- Development of computer software validation efforts CFR 21, part 11 and test codes, writes and /or executes software test scripts

- Assist in the training of users, writing and perform training modules along with technical support for user and managers questions.

- Provide the support to Core Team, Manufacturing Process and Laboratory System Operations.

- Subject Matter Expert and provide support to External Site Operation as NJ, NY, PA, Guayama-PR, Carolina-PR

- Experience Labware LIMS configuration for Test Method and Applicable Product Specification for Raw Material, Intermediate,

Final Product, Stability, Retain, Complaint, Cleaning and Validation Manufacturing Samples.

- Labware Instrument Configuration is applicable to HPLC, GC, Dissolution Apparatus, Balance, Thermometer, Caliper, Column,

Oven, Karl Fisher, IR Spectrophotometer, Water Bath, Shaker and others.

- Labware Standard and Reagents Configuration are applicable to Purchased and Home Prepared Solutions.

- LIMS Interface configuration experiences with Empower, Balance, Caliper, PH Meter, SAP QM, OpenLab and Crystal Report.

- Experiences with Charting and Minitab to integrate Control Chart, Cpk, Histogram, Pareto, Regression and Frequency.

Education:

Graduate Bachelor’s Degree in Science - Major Chemistry, Sagrado Corazón University, Santurce, P.R

Professional Chemist license 2389.

Seminars:

GMP’S, GLP’S, SPC, IQ-OQ-PQ, ISO, FDA, DEA, Safety, Labor relations, Sexual Harassment, Supervision, Cleaning validation, Computer; Excel, Word, Power Point, Statgraphics, SAP system, Trackwise, GxPharma, Open Lab, SQL* LIMS, Empower, Minitab, Turbochrom, MSM, Crystal Report, Yellow and Green Belt Certification, Certified Labware LIMS Administrator, LIMS Basic, Labware Labstation, Project Management and Change Management.

References: Will be furnished upon request.

Marcelino Rodriguez, 787-***-**** / Harry Acosta 714-***-**** / Shelly Cruz, 787-***-**** / Luis Calimano 787-***-****

Contact this candidate