Project Manager Quality Assurance

OBJECTIVES

A highly competent and results-oriented professional with extensive Quality Assurance expertise, seeks to contribute experience, skills

and capabilities, while promoting company’s growth.

CORE COMPETENCIES & SKILLS

15 years of successful pharmaceutical Organizational ability.

+

Outstanding strategic planning

Quality Assurance expertise. abilities.

Systems validation protocols.

Fully knowledgeable of pharmaceutical Attention to details.

Acquainted with the FDA, EDQM, EPA,

industry practices and procedures. Good team building aptitude.

OSHA regulations and 21 CFR Part 11.

Pharmaceutical industries operations, Food and Drug Administration inspections Unique decision making capacity.

practices and logistics knowledge. and submissions. Problem solving skills.

Lab instrumentation preventive Management and Supervision capabilities. Fully bilingual (English-Spanish).

maintenance, calibration and qualification.

LIMS LabWare, Empower, SAP, Computer proficiency: MS Office;

Superior analytical skills. Validation and CALMAN, GxPharma, MES SMS-SQ and Excel; Power Point; Internet;

Certification of Raw Material and Trackwise. Network Configuration; MS Project

Packaging Components supplies

Creating and closing Change Control for Application.

compliance within the company policies

different areas in the company.

and cGMP requirements.

ACHIEVEMENTS

Performed the CDAS systems (Perkin

Directed startup of the Consumer

Health Care area’s new laboratory; Elmer Turbo Chrom) validation update in

operations met established time and the new servers.

budget goals. Created the Consumer Health Care

Was designated as the backup area system and calibration for the PM;

Administrator for the CDAS systems resulted in enhanced QC operations,

(Waters Empower). instrument up-time and documentation

completeness. Lab Equipment and

Supported the new Development

Instruments Qualification, Facilities

Lab’s validation of new instruments and

Qualification, Statistical Application

computer system; contributed by

knowledge, Scheduling Application, MS

accelerating the validation process to meet

Project application, and Computer System

required schedule.

Validation.

Created protocols for software

Configuration the LIMS –Labware

instruments validation, key for the lab

templates.

operations startup, include micro-lab.

Recognized for more 18 years of

As Calibration Coordinator, achieved

perfect attendance.

zero observations during FDA inspections.

Project Manager Consumer Health

Configuration the LIMS –Labware

Care area new laboratory y facilities.

templates.

PROFESSIONAL EXPERIENCE

Wyeth Pharmaceutical, Guayama, PR 29 June 1984 -29 July 2009

Senior QC Scientific I (1 Nov 2004 - 29 Jul 2009)

Supervised staff daily activities, coordinating and adjusting work assignments to complete needed tasks.

For one year performed the Labware LIMS configuration for finish products, raw, stability, and packing components.

Coordinated calibration and PM for the laboratory instruments with outside contractor.

Designated Group Leader; supervised five (5) employees.

Completed the verification and managed the reports performed for external and internal technicians. Revised calibration and PM

procedures and modifications to ensure compliance with regulations. Maintenance Planner Scheduler and tools necessaries

Verified and managed the reports performed by external and internal technicians in 5 Lab, include micro-lab instruments and

aseptic areas.

Maintained all records, log books, and computer files in a neat and orderly fashion.

Provided documentation of all work activity requiring manual calculations and maintaining a lab notebook for all non-routine

requests.

Performed and recorded recommended routine calibrations and maintenance on all lab equipment to ensure compliance.

Made the validation and qualification procedures for new instruments, equipment’s and computer software. Prepare Protocols and

SOP.

Creating and closing Change Control for different areas(Quality Control, Infrastructure Technology in Computer System and

Servers, Suppliers of components of manufacturing and packaging validation, IQ, OQ, PQ, Risk Management and other states of

the lifecycle including Assets and Risk for equipment’s and Instruments) in the company.

Validation and Certification of Suppliers. Prepare the Master Master Plan

Senior Analyst (1 Jan 2000 – 31 Oct 2004)

Oversaw the data acquisition system of calibration and PM of the instruments in the Consumer Health Care area.

Participated in troubleshooting, investigation and problem solving meetings.

Supported internal and external audits and worked with internal departments.

Evaluated, verified and released protocols records of instruments and software’s

Administrator for CDAS system.

Write the procedure for analytical instruments and equipment’s in Gx-Pharma for IQ, OQ, PQ, etc.

Creating and closing Change Control for different areas in the company.

Project Manager Consumer Health Care area new laboratory y facilities.

Validation Equipment’s, Instruments and Facilities leader.

Created the SOP new for instruments and equipment’s.

Lab Analyst IV (1 Jan 1995 – 31 Dec 2000)

Designated Group Leader; supervised twelve (12) employees.

Conducted laboratory tests.

Ensured strict adherence to quality control in testing cycle through inspection of lab systems and associated components.

Assisted to comply with Current Good Manufacturing Practices (cGMPs).

Verified the records of the laboratory.

Participated in FDA inspection the laboratory records.

Trainer the new analysts.

Lab Analyst III (1 Jan 1990– 31 Dec 1995)

Conducted laboratory tests, as part of surveillance testing, stability testing and method validation.

Performed a variety of analytical testing techniques; reduced and prevented errors when executing laboratory testing.

Lab Analyst I (29 June 1984–31 Dec 1990)

Conducted laboratory tests; participated in troubleshooting and assisted in all lab analyses.

Carried out a variety of testing techniques.

E D U C AT I O N

Inter-American University of PR, Guayama, PR

Master Degree in Science; Major: Network and Security (in process)

Inter-American University of PR, Guayama, PR

B.S. Degree in Computer Systems; Major: Reparation and Programming; 2005

Inter-American University, San Juan, PR

MBA Management; Major: Industrial Management and Accounting; 1993

Catholic University, Ponce, PR

B.S. in Chemistry; 1981

OTHER COURSES & SEMINARS

American Society for Quality – Fundamentals of Advanced Instruments- Metrology of Laboratory

Quality Engineering; 48 hrs. Balance; 16 hrs.

Measure Assurance Specialist- regulatory Aspects of Excel; Computer Institute; 12 hrs.

the Calibration Program; 24 hrs. Microsoft Windows System Validations;

SAP Corrective Action and Preventive Action (CAPAS). Computer Institute; 12 hrs.

SAP Materials Management. SAP Change Control.

SAP Purchasing. SAP Preventive Maintenance.

Time Management, PR Industrial Development Validation Computer System; Wyeth; 48 hrs.

Company. Waters Separation Module 2695 Use Training; 8

Waters Empower-1 CDAS; 40 hrs. hrs.

MS Project; 8hrs Lean Six Sigma training ;24hrs

Validation Life Cycle Training; 16hrs

REFERENCES

To be furnished upon request.

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