Manager Project

RESUME

Luis A. Jim nez Silva

Urb. Villa Turabo, D6, Cipres Street.

Tel. 787-***-**** Mobile or Home 787-***-****

Caguas, P.R. 00725

E-Mail: ***************@*****.***

Available to Re-localization

Skype: luis_jimenez_silva111

EMPLOYMENT HISTORY:

Wyeth/Pfizer Pharmaceutical, Guayama and Carolina Sites, P.R.

04/2002 to 11/2012

Business Technology Analyst (CSV- 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, Trackwise, GxPharma, Pdocs, Plateau, Work-Tickets, Isotrain,

MES, OpenLab, SAP QM, Crystal Report and Minitab.

. Primary responsibilities include Project and Change Management for

Validation Deliverables, Revision, Bugs, Upgrades, New Release,

Decommission, Improvement, Disaster Recovery, SOP, Training, Data

Migration, Security, Documentation, Maintenance and Enhancement the

Quality System and Business Operations.

. Software Implementation: Handling the Change Control activities,

Validation Deliverables, Strategy of Project Plan, Evaluate Technical

Designs and Specification Functional Requirements for Laboratory and

Business Automation.

. In Project Management coordinate the activities of team members for

Validation, Master Data, SOP, Training and create the following

documents in order to define validation requirements as: Workflow As

Is, Workflow To Be, Functional Requirements, Change Control, Project

Plan, Validation Plan, Training Plan, SOP Plan, Impact Assessment,

Traceability Matrix, Master Data Built Objects, Validation Summary, IQ-

OQ-PQ Summary, Disaster Recovery, Backups, User Guide, Work

Instructions, Training Job Aids,Test Script Executions, Excel

Spreadsheet, Team leadership and Experience leading cross-functional

teams and Statistical Analysis.

. Development of computer software validation efforts CFR 21, part 11

and test codes, writes and /or executes 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 Global Core Team: Information Technology, Manufacturing Process and

QA/QC System Operations. Also support to External Site Operation as

NJ, NY, PA, PR.

. Labware LIMS Deployment: Experiences in coordination and deployment

for Master Data Team Build Objects, Standard & Reagents, Instruments,

Labstation, Chemical and Microbiology Analysis, Product

Specification, Environmental Water, Air & Surface, Chart & trends,

Menu & Toolbars, Security Users & Roles, Sample Manager, Labels,

Reports, Project Validation Samples, Master Data Pack Documents and

data migration from Development to Quality and then to Production

environments.

. Experience Labware LIMS configuration for applicable Product

Specification: RM, Intermediate, Finish, Stability, Retain, Cleaning

Validation and Projects

. Labware Instrument Configuration is applicable to HPLC, GC,

Dissolution, IR, KF, AA, Printers, Columns and

LabStation applicable to instrument interface: Balance, Caliper,

PH Meter and UV-Visible.

. Crystal Report configuration: Product History, Sample Label, COA, Test

Results, PM Instrument, S&R, Stability.

. LIMS Interface configuration: Experiences with Empower CDAS, SAP QM,

Trackwise, OpenLab and Minitab - Statistical Software packages. (Lean

and Six Sigma Process of Excellence Evaluation)

. Empower Application(CDAS) provide support to Laboratory Operations and

define Strategy Implementation for Validation Deliverables, User Roles

functional priviledge, Data Configuration for Instruments, Processing

Method, Custom Field, LIMS Mapping, Method and Sample Sets. Also bring

support to User and Manager in order to monitoring Change Control

activities related to Project or Protocol Validations, IQ-OQ-PQ, Test

Scripts, Testing,

Commitments, Investigations, Trainings and SOP'S.

. MES application provide support to Business Operation and define

Validation Deliverables, Material Work-Flow, Configure Weight

dispense, Cleaning parameters, Scale, Equipment, Safety Material

Precautions and Test Scripts. Also bring support to User and Manager

in order to monitoring manufacturing executions, User Training and

SOP'S.

Davis & Geck, Chemical Plant/ US Surgical Corp., Manat, P.R.

02/1998 to 03/2002

Laboratory Supervisor

. Supervise the chemical and microbiological laboratory testing for two-

shift operation.

. Assure the proper use of the laboratory resources to support technical

functions in the validation /qualification process in manufacturing

operations.

. Coordinate activities of Product Disposition, OOS and Investigation

report. Evaluated Trend Analysis, Metrics, Charting, Annual Product

Review, Corrective Actions and Compliance Audit Inspection.

. Also assisted implementation and support validation of SAP QM Module

in Puerto Rico and Santo Domingo operations.

Zenith Pharmaceutical/ Ivax Corp., Cidra, P.R.

10/1994 to

01/1998

Senior Chemical Analyst

. Responsible to coordinate chemical laboratory testing for raw

material, stability and finished products in second shift operation.

. Experienced with reviewed and approved analytical test report. Assure

laboratory personnel follow proper testing standard procedure, GMP'S,

GLP'S and Safety precaution.

. Perform and evaluated laboratory investigation report and assure

corrective action to prevent recurrences.

. Experienced with IQ, OQ, PQ, Protocol, Cleaning Validation,

Calibration, Documentation, SOP, Trends, Charting, APR, Regulatory

audit by Safety, DEA, FDA.

. Also experienced with the following chemical analysis: GC, HPLC,

UV/VIS, IR, Dissolution, Karl Fischer, TLC, PH meter, Microscopy

particle examination and others.

Reedco/Dentco, Pharmaceutical/ Block Drugs Corp., Humacao, P.R.

04/1990 to 09/1994

Process and Packaging Supervisor

. Coordinate Aseptic formulation, Sanitization, Change Over, Weighing,

Cleaning, Glassware and Filling operations.

. Handling WFI, Tanks, Nauta, Koruma, Kettles, Pumps, Mixers,

Blenders, Mills, Transfer Line, Chiller, Tubing, Oven and Filtration.

. Experienced with Adhesives, Paste, Cream, Shampoo and Supervision

employee's activities to assure the proper use of these resources.

. Performed Manufacturing Investigation report, Packaging

reconciliation, SOP revisions, Protocol, GMP'S and Safety training,

Personal evaluation, Special Project Management, Regulatory documents

and inspections.

EDUCATION:

Graduate Bachelor's Degree in Science - Major Chemistry

Sagrado Coraz n University, Santurce, P.R

Professional Chemist license 2389

SEMINARS / SKILLS:

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 QM, Trackwise, GxPharma, Open Lab,

Labware LIMS v5 and v6, SQL* LIMS, Empower, Minitab, Turbochrom, MES,

Crystal Report, Yellow and Green Belt Certification applicable to Process

Excellence or Six Sigma Evaluation, Labware LIMS Administrator, Project

and Change Management applicable to Change Control requirements, Leans

Management applicable to laboratory operations, PL/SQL, Oracle, Citrix,

Query, LIMS Basic, Labstation and Computer System Validation.

REFERENCES:

Marcelino Rodriguez, 787-***-****, Director Quality Operation

Harry Acosta, 714-***-****, Director Quality System

Shelly Cruz, 787-***-****, Co-Worker Associate Quality

Manager

Luis Calimano, 787-***-****, Co-Worker Quality Manager

Brenda Ruiz, 787-***-****, Co-Worker Project Manager

Exor Vargas, 787-***-****, Co-Worker IT Analyst

Contact this candidate