Quality Assurance Project Manager

Summary of Qualifications

Quality Assurance, manufacturing and Validation professional with over

twenty years of experience in the Pharmaceutical and Medical Devices

Industry looking for an opportunity to broaden experience within the

quality assurance, manufacturing or technical field. Self starter, used to

work in a fast pace and constantly changing environment. Fast learner,

willing to be trained in new areas of development. Team player, with

knowledge in non-conformances investigation and problem solving, Document

Review and Quality Assurance. Hands on experience in the execution and

development of validation, manufacturing and quality assurance protocols,

product transfer and special projects. Broad exposure to equipment (tanks,

ovens autoclave, tunnels dryers HVAC, HEPA) and utilities (water, nitrogen,

compressed air) qualification and depyrogenation, steam and ETO

sterilization processes (Cycle development and troubleshooting of medical

devices and ophthalmic solutions). Willing to relocate and /or travel.

Excellent communications skills and interpersonal relationships.

Experienced leading interdisciplinary groups for the achievement of project

goals. Experienced in Regulatory Compliance, Quality Systems Experienced

dealing with FDA and regulatory inspections. Cross-functional experience in

supervising bulk manufacturing operations. Recognized among piers as a good

trainer with excellent communication skills, capable to communicate

effectively at all levels and interact supportively within a team

environment.

EDUCATION

BS General Science, University of Puerto Rico, Rio Piedras Campus

YEARS IN THE

INDUSTRY: 20+

Jorge L. Hern ndez & Associates Aug 2005 to present Specialties:

Provide Quality Assurance and Validation services to clients, Quality Assurance

including development of operational procedures, validation Validation

protocols and summary reports and Annual Product Reviews. Technical Services

Provide support in compliance issues and strategies. Manufacturing

Pharma-Bio Serv Compliance and Validation Services Dec 2005 to

Feb 2009 COMPUTER/ CONTROLS:

Provide Quality Assurance and Validation services to clients, MS Word

including development of operational procedures, validation MS Excel

protocols and summary reports and Annual Product Reviews. MS Power Point

Provide support in compliance issues and strategies. Kaye Systems

Work as project manager of multidisciplinary teams to assure Trackwise

completion of projects in a timely manner. Documentation

included Commissioning as well as Installation, Operational and EQUIPMENT:

Performance Qualification protocols and Summary Reports. Autoclaves

Pharmaplan-Flaval Compliance and Validation Services Aug 2004 to Dry heat oven

Aug 2005 Depyrogenation

Provide Quality Assurance and Validation services to clients, Tunnels

including development of operational procedures, validation Labelers

protocols and summary reports and Annual Product Reviews.

Provide support in compliance issues and strategies. UTILITIES:

Work as Quality Control Manager and Project manager of Water for injection

multidisciplinary team to assure completion of project in a Nitrogen

timely manner in a Biotech Facility Start up (Amgen, Puerto Compressed Air

Rico). Responsible for the verification and approval of Steam

documentation (Commissioning as well as Installation,

Operational and Performance Qualification protocols and Summary QUALITY SYSTEMS:

Reports) to be submitted for client approval, also responsible Annual Product

for the daily follow up and resolution of schedule and field Reviews

execution issues. CAPA

Foster-Wheeler LTD Aug 2002 to Jul 2004 Investigations

Provide Quality Assurance and Validation services to clients, Change Control

including development of operational procedures, validation SOP's

protocols and summary reports and Annual Product Reviews.

Provide support in compliance issues and strategies. INDUSTRIES:

Work as Quality Control Manager and Project manager of Pharmaceuticals

multidisciplinary team to assure completion of project in a Semi Solids

timely manner in a Biotech Facility Start up (Ortho, Pharmacia Solids

Upjohn, Pfizer, Cordis). Responsible for the verification and Parenterals

approval of documentation (Commissioning as well as Medical Device

Installation, Operational and Performance Qualification

protocols and Summary Reports) to be submitted for client

approval, also responsible for the daily follow up and

resolution of schedule and field execution issues. PROFESSIONAL

Schering-Plough Products, Manat Operations Apr 1986 to Aug AFFILIATIONS/

2002 MEMBERSHIPS

Certification of HEPA filters, Qualification of equipment Member of the

(ovens, autoclaves depyrogenation tunnels and multiple American Society for

equipments) and utilities (water, air, nitrogen and steam), Quality

Provided support to Quality Assurance and Validation services,

including development of operational procedures, validation

protocols and summary reports and Annual Product Reviews.

Provide support in compliance issues and strategies.

Worked as manufacturing supervisor of a bulk manufacturing

facility. Responsible for the Finishing area team (eight

operators) and completion of manufacturing schedule. Development

and execution of ETO Sterilization cycles of plastic components.

SELECTED EXPERIENCE

Stryker, Arroyo, PR

Development of ETO and Gamma Sterilization Cycles

Troubleshooting of existing cycles to assure compliance with

validated conditions,

Janssen Manufacturing, J & J, Gurabo, PR

Development and issuance of Commissioning Report.

Development and issuance of Qualification Report.

Alza Manufacturing, J & J, California, US

Coordinate Project: CAPA and Investigation closing strategy;

focusing on investigations.

Evaluate Manufacturing, Warehouse, and Calibration

investigations.

Responsible for the approval and closure of investigations.

Perform Quality Assurance investigations..

Support CAPA activities.

Create and update Quality Systems metrics

Coordinate Validation documentation review

TAPI, Guayama, PR

In charge of Generating Annual Product Reviews at TAPI Guayama.

Coordinate Project: Change Control, CAPA and Investigation

closing strategy; focusing on investigations.

Perform investigations for Manufacturing, Warehouse, Quality

Assurance and Engineering Departments.

Support Change Controls and CAPAS closing activities.

Complete Packages for Change Control closing.

Support feedback for drawings update, SOP revisions,

Cleaning/Manufacturing Letters revisions and Annual Product

Review completion.

Create and update Quality Systems metrics

GlaxoSmithKline

Provide Validation, Quality Assurance and Compliance services to

clients as an independent consultant.

Present solutions to clients using technical knowledge and

previous experience.

Lead clients to the achievement of business and Quality goals.

Lead Annual Product Review team.

Bristol Myers Squibb, Humacao, PR

Development of Annual Product Reviews

Qualification Documentation Reviewer

Assess Corrective Action/Preventive Action system and recommend

preventive actions to avoid recurrence.

Provide Technical and Quality Assurance Support to clients.

Provide support to Change Control Program.

Amgen Manufacturing Limited, PR

Development of Annual Product Reviews

Qualification Documentation Reviewer

Assess Corrective Action/Preventive Action system and recommend

preventive actions to avoid recurrence.

Provide Technical and Quality Assurance Support to clients.

Provide support to Change Control Program.

Ortho Manat , Pharmacia Arecibo (Pfizer) and Cordis San German,

PR

Development of IQ/OQ/PQ Protocols for Manufacturing Equipment

Qualification.

Protocol Execution.

Issue Final Summary Reports

Qualification Documentation Reviewer

Provide Technical Support to clients.

Interim Team Site Leader coordinating ten validation

specialists.

SPECIALIZED TRAINING:

Quality Risk Management: ICH Q8, ICH Q9, ICH Q10

Knowledge of regulations and cGMP's

Equipment Qualification including protocol preparation and

execution

Facility Qualification including protocol preparation and

execution

Process Troubleshooting

Equipment Start-Up Project Management

Process Improvement project implementation.

Proficient in the use of PC software applications.

Manufacturing Department Supervision

Kepner-Tregoe Problem Solving Method Trainee

Variance investigation

Project Management

Handling of Corporate and FDA inspections

Manage Safety and GMP programs

Qualification / Validation of Processes

Systems for Sterile Pharmaceutical Products - Center for

Professional Advancement (1990)

Design and Operation of Clean Rooms- Richard Austin (1992)

Supervisory and Managerial Skills- Rockhurst College (1999)

Management Skills- Raul Salgado (1999)

Problem Solving and Decision Making Analysis (Green Belt

Training)- Kepner -Tregoe (2001)

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