Management Quality

Ramón Quiñones-Cerezo

HC * Box ***** / Las Mansiones

Aguadilla, P.R. 00603-9375

787-***-**** / *****.********@*****.***

Professional Summary

Professional with experience in CAPA, Change Control, Cross-functional Team Leadership, FDA, GMP, Regulatory Requirements, Root Cause Analysis, Technical Writing, Technology Transfer, laboratory systems and instrumentation, food, pharmaceutical, biotechnology industry processes, practices and systems.

Accomplished technical compliance mentor and trainer.

Knowledge of computer systems migrations / conversions / validation / decommissioning processes, internal / external compliance audit program, development and implementation of operational and systems quality standards.

Leader with the ability to empower peers to commit to high-level performance.

Self-starter, responsible, excellent interpersonal skills and teamwork oriented with the ability to become integral resource to a dynamic organization and align associates with shared vision.

Effectively integrates into high technology work environments.

Completely fluent in Spanish and English languages.

Academic instruction in Computer Sciences.

Accomplishments

Attain highest commendations from peers, reporting management chain of command, as well as serviced personnel from other departments, and regarded as experienced and resourceful associate, able and willing to execute as needed, always with highest safety and quality standards, during and upon completion of two year assignment as QA CSV Lead, during Consent Decree workplan.

Achieve high level of satisfaction from clientele of nearly one hundred individuals on hardware/software issues on wide spectrum of situations including configuration, installation, and training, and operation support during extremely demanding conditions.

Completed regulatory compliance remediation workload of laboratory systems as part of pharmaceutical plant operations closure.

Hands on experience in testing of SAP core deployment, changes, upgrades and migrations.

Play key role in completing Consent Decree computer validation systems workload, as project leader of up to thirteen computer system validation specialists, two weeks ahead of time, with zero regulatory observations. For all practical purposes, this project became preamble of a successful site decommissioning and closure process, due to immediate closure of site upon Consent Decree certification.

Attain high management commendations for effectively responding on compliance issues resulting in zero observations, during several internal and external regulatory audits on computer validation.

Highly regarded external compliance and technical resource to world leader Pharmaceutical Corporation, in multiple projects, at three sites in Puerto Rico, four sites in the USA, two sites in Brazil, three sites in Mexico, and sites in the following European locations: France, Italy and Ireland, intermittently, during a time span of over twenty years.

Attain highly commended fast track testing of SAP core deployment, changes, upgrades and migrations, by switching own time zone to time zones of other regions providing support for duties at hand, under extremely aggressive schedules.

Achieved savings of $70k+ during first quarter of implementation of calculation and reporting tools, that improved personnel efficiencies, enhanced data handling reliability. This task was completed in full compliance with quality system requirements, regulatory rationales, industry practices, and corporate guidelines.

Led two highly regarded record-breaking implementation assignments of in-house QC information system for world leader Pharmaceutical Corporation, for five manufacturing sites; two in Brasil, and three in Mexico.

Professional Experience

Qualitech Management Solutions, Añasco, PR

QUALIFICATION AND VALIDATION CONSULTANT 2015

Responsible for ensuring that GxP regulated computerized and automation systems within biotech manufacturing facility are in full compliance with regulatory requirements, company policies and procedures. Provides compliance leadership and mentoring, direction and oversight to project team in Computer System Validation, and manufacturing processes.

McNeil Healthcare LLC, Las Piedras, PR Dec 2012 – Dec 2014

LEAD COMPUTER SYS VALIDATION, QA - CD

Responsible for ensuring: that GxP regulated computerized and automation systems are in full compliance with regulatory requirements, company policies and procedures; the quality oversight of GxP regulated computerized systems (e.g., manufacturing plant and laboratory systems, and enterprise applications). Provides compliance leadership, direction and oversight to project teams in Computer System Validation. Extensive exposure to initiatives covering: building management systems, network infrastructure, solid dosage manufacturing equipment, packaging and labeling lines, vision inspection systems for product/process, temperature mapping of manufacturing and warehouse areas, laboratory systems and instrumentation.

Casa Grande Interactive Communications, San Juan, PR Nov 2011 – Jul 2012

Quality and Data Security Lead (Short-term Contract)

Support Information Technology area for ‘family owned’ business on diverse tasks including: hardware (laptops, desktops, printer/copier/scanner/fax, modems, audio-visual, etc.) inventory and best utilization, basic server and networking troubleshooting, intensive and extensive support to 100+ users, of which 80+ were ‘road warriors.’ Exposure to supplier negotiations, equipment evaluation, personnel training, tool development, and daily operations support.

STS Consulting, East Brunswick, NJ Nov 2007 – Oct 2009

Consultant (Professional services)

On project basis, served as Site Quality Assurance validation agent, at world leader Pharmaceutical Corporation, for the revision and approval of

Validation documentation covering Programmable Logic Controllers / Distributed Control System, automation within biotechnology manufacturing facility

WATERS-Empower periodic review

PHARMAK Group Corporation, Inc., Caguas, PR Nov 2006 – Oct 2007

Consultant (Professional services)

Develop and execute remediation documentation for laboratory instrumentation (Agilent 1100) at Mayne Pharma (PR) for plant decommissioning and closure.

Assess regulatory compliance of startup Quality System for computer management at Hewlett-Packard, Aguadilla.

Schering-Plough Products, LLC, Manatí, P.R. Feb 2002 – Aug 2006

Computer System Validation, Project Leader

Project Management of laboratory systems and instrumentation, computer system validation requirements per workplan defined by Consent Decree.

Performed QA for sampling strategy during MP2 conversion process.

Reviewed and approved validation documentation (i.e., Plans, Requirement Specifications, Protocols, and Summaries) during CFR Part 11 legacy systems remediation project.

Developed System Life Cycle documents for NuGenesis SDMS, InnovaSystems Nasal Spray Pump Dosage Weight Station (NSP DWS), and Mini Robotic Proofreader.

Validation and Training Services, Inc. (VTS, Inc.), Manatí, P.R. Nov 2000 – Feb 2002

Independent Contractor

Developed and executed validation protocols for gaseous distribution systems; compressed air and nitrogen.

Prepared System Life Cycle documents for Apogee / Building Management System to service both sterile and non-sterile pharmaceutical manufacturing areas.

Revised Piping and Instrumentation Diagrams (P&ID) for plant-wide gaseous distribution systems.

Bristol-Myers Squibb, Princeton, NJ Feb 1997 – Jul 2000

Manager, Laboratory Information Systems – Global Business Service Department

Supported corporate standard application users in the USA, France, Ireland, Italy and Puerto Rico

Member of core team responsible to design, develop, test, train, deploy, and maintain global computerized applications.

Prepared and executed test scripts for interface between Beckman Laboratory Information Management System (LIMS) and SAP Quality Module (QM/QM-IDI).

Active member of worldwide SAP deployment team for sites across different time zone, languages, cultures and customs. Hands on experience in testing of core deployment, changes, upgrades and migrations.

Global Computer Services, Inc. Syracuse, NY Dec 1996 – Feb 1997

Consultant to Bristol Myers Squibb

Core team member of Quality Engineering for the strategic and logistics of corporate re-engineering initiatives to augment and standardize computerized systems by modeling policies and procedures based on best practices.

Satellite resource to support Quality Engineering model at Barceloneta, Mayaguez, Humacao, PR.

Soderlhom Consulting Services, Inc./Global Computer Services, Inc., Syracuse, NY Sep 1995 – Dec 1996

Consultant to Bristol Myers Squibb

Established operating standards for Quality and Engineering global support group

Supported testing and maintenance of global computerized business application

Prepared reports and presentations to support corporate strategic plans

Deployed corporate Quality Management Information System at Naucalpan, San Angel, and Tlalpan, Mexico

Pfizer Pharmaceuticals, Inc., Barceloneta, P.R.

QA Systems Specialist Dec 1993 – Sep 1995

Pharmaceutical Plant Validation Review Board coordinator / Organic Synthesis Plant Validation Review Board coordinator back-up

Pharmaceutical Plant cGMP Audit Program coordinator / Organic Synthesis Plant cGMP Audit Program coordinator back-up

Continuous Improvement Process QA team member

Custodial of regulatory submittal packages and responsible to maintain corresponding databases.

Coordinated validation efforts for laboratory systems and instrumentation and manufacturing area systems and processes

Performed QA for sampling strategy during BPCI/MAPICS conversion process

QA Laboratory Analyst II Dec 1991 – Dec 1993

Lead initiative to control use of Lotus Spreadsheets within QA/QC laboratories.

Developed/Validated/Deployed secured calculation and reporting platform for laboratory testing results.

Hands on during validation execution of Laboratories Information System.

Support on routine laboratory environment activities.

Self-Employed Nov 1991- Dec 1991

Consultant / Technical Advisor

Bristol-Myers Squibb, Co. at Syracuse, NY – strategic and logistics corporate planning for Quality Management Information application deployment abroad

Bristol-Myers Squibb, Co. at Sao Paulo, Brazil – highly commended corporate Quality Management Information application deployment

Bristol-Myers Squibb, Mayaguez, PR

Operations Analyst / Quality Department Dec 1988 – Nov 1991

Point of contact with corporate Quality Engineering for deployment of best practices

Point of contact with site and off-site company departments regarding best utilization of management information systems.

Local Corporate QA point of contact during planning, proof of concept, construction, and validation of non-Lactam oral pharmaceuticals products building. Including FAT/SAT for computerized manufacturing systems at Texas Instrument facilities, Baltimore, Me.

Successful semi-manual conversion of 600+ validation deliverables into MS Word format related to the efforts for the non-Lactam plant.

Quality Department operational budget development and overall control and reporting.

Electronic Data Processing Specialist / Quality Assurance Dec1986 – Dec 1988

Deployment of QA supporting functionality of Quality Management Information System

Point of contact with IM/IS department for all things technical related to system being deployed

Development of training materials related to system being deployed.

Coordination and provision of training sessions to user community as pertinent to their respective functional areas: quality laboratories, quality assurance, materials management, engineering, finance, administration.

Chemistry Laboratory Assistant Dec 1985 – Dec 1986

Deployment of QC supporting functionality of Quality Management Information System

Point of contact with IM/IS department for all things technical related to system being deployed

Development of training materials related to system being deployed.

Coordination and provision of training sessions to user community as pertinent to their respective functional areas: quality laboratories, quality assurance, materials management, engineering, finance, administration.

Data entry activities related to generation of Quality Certificates of Analysis

General analytical testing activities within anti-cancer parenteral pharmaceutical products.

CapsuTabs / BMO / Nutritional Specialties, Inc., Arecibo, PR. Sep 1983 – Jul 1985

Chemist

General analytical testing activities within multi-vitamin products.

Raw material / plant waters sampling and testing.

Lead initiative to innovate overall operations within laboratory operations introducing use of computers and automated systems.

As licensed chemist, signature of Quality Certificates of Analysis.

Education

University of Puerto Rico, Mayagüez, PR.

BS – Major in Analytical Chemistry, Minor in Mathematics

(Courses taken in computer programming languages and systems analysis)

Training

Among several others gathered during over 30 years’ experience:

Team Building

Leadership Effectiveness

Time Management

Kepner Tregoe Decision Making/Problem Solving, Project Management

SAP/Quality Management

Current Good Manufacturing Practices (cGMP)

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