Reinaldo Cruz

Mobile 787-***-****

accshn@r.postjobfree.com

SUMMARY OF QUALIFICATIONS

Quality oriented professional with over 26 years of direct experience with

FDA regulated industry. Background includes Pharmaceutical and Medical

Device. Experience in Meet the program objectives by planning and directing

Project Manager tasks. Identified issues and established the disciplines

necessary to fulfill the program deliverables. Provided direction to

support activities as necessary.

PROFESSIONAL EXPERIENCE

Patheon Mexico, DF..

2013

Senior Quality Systems Consultant

. Designed, developed, and implemented quality and regulatory

compliance initiatives and programs, strategic planning for

manufacturing operations located in North and South America,

manufacturing sites.

. Responsible for the quality and product release of all purchased

components, raw materials, intermediates, drug substance, finished

product, as well as the regulatory and NDA conformance at domestic

and international contract manufacturing sites.

. Reviewed Validation requirements and developed strategies to

prevent deviation (Gap-Analysis)

. Designed, developed and implemented Deviation Management, Change

Management, Record Management and CAPA Programs.

. Trained various Departments in Qualification activities

Sanofi Pasteur, Swiftwater,

PA

..2013

Project Manager / Product Transfer

Manage Product Transfer and Validation activities from France to PA

facilities such as:

. Risk Assessment

. Developed Small Scale Stability

. Formulation Process Design

. Developed Manufacturing MBR

. Developed Formulation and Filling Process Drawing

. Developed Equipment Qualification

Hospira, Rocky Mount,

NC

2011 to 2012

MQA Consultant

Review Lifecycle documents, Assessments, Qualification Protocols, and

Summary Reports including, but not limited to:

. Serving as interim QA Manager and Manufacturing Quality

representative to facilitate the achievement of quality goals

. Provide GMP compliance consultation and coaching/mentoring for

continuous improvement

. Provide oversight monitoring/verification to ensure that processes

and associated controls are executed and documented correctly

. Reviewed and revised departmental SOPs

. Identify opportunities for process improvements and support

remediation/implementation

. Designed, developed and implemented Deviation Management, Change

Management, Record Management and CAPA Programs

Reinaldo Cruz

Mobile 787-***-****

accshn@r.postjobfree.com

PROFESSIONAL EXPERIENCE

Wyeth, Guayama, PR

2010

Project Manager / CSV / IT

. Provide guidance on new FDA regulated products and methods

validation including: documentation review/ GAP analysis, change

controls, CAPA, Review Standard Operating Procedures {SOP}, and

implement improvements as required Review and evaluate validation

assessments for application systems / projects.

CSV / IT Audit

. Review validation protocols for accuracy and conformance to company

policies in IS Department, Microbiology and Chemistry Lab.

. Review Standard Operating Procedures {SOP}, and implement

improvements in IT Department as required Review and evaluate

validation assessments for application systems / projects

. Review and track document completion dates. Provide follow up with

reviewers to ensure timely completion of documents reviews and

approvals.

. Review and maintains control of System Documentation both manually

and Electronic Document in IT Management Systems Department.

. Hardware requirements, where I verified the following workstation

such as: monitor, CPU, mouse pointer, printer floppy disk, CD-Room

and USB drive installation and client/workstation software where I

confirmed the minimum software requirement for use in-house

. User groups and privileges where I created system security to

restrict access to some users or groups such as: open method, save

method, open spectrum, manipulated spectrum, run method, stop

method, print report, backup/recovery, add users, add groups,

verified audit-trail and set clock

Wyeth, Guayama, PR

2007 to

2009

Project Manager CSV

. Managed all Validation work according to Good Manufacturing

Practices (GMP)

. Coordinated with Manufacturing and Quality Departments all

Validation activities

. Managed Qualification program in Chemistry and Microbiology Lab.

. Prepared Validation Plan and provided necessary support to all

strategies

. Trained various Departments in Qualification activities

. Developed Validation Master Plan

. Developed and summarized all Validation Protocols for CSV, Empower,

IT and DeltaV

. Review Validation Plans and Protocols and ensured products met

required needs

. Reviewed Validation requirements and developed strategies to

prevent deviation (Gap-Analysis)

. Review test protocols for pre-approval and approval of this

Validation Plan, review results and final report for compliance

with cGMP and company policies

. Review the deviations during protocol execution

. Report the validation project status completion, including system

status and identification of areas of weakness that impede the

completion of tasks

Reinaldo Cruz

Mobile 787-***-****

accshn@r.postjobfree.com

PROFESSIONAL EXPERIENCE

Roche Diagnostics, Ponce, PR & Indianapolis Head Quarters

2006

Project Manager CSV/ 21CFR Part 11 Requirements

. Developed system classification, {IOQ} and {PQ} to Agilent 1200, Culligan

RODI System Water and Microcentrifuge Eppendorf 5810R and 5415D

. Develop assessments to Part 11, {IOQ} to DU WinConnetion software Suite

and TotalChrom software.

. Developed Laboratory SOP, Traceability Matrix and Final Report.

. Performed as part of the validation but not limited different test such

as: Critical Screens with valid/invalid data entries, Critical alarms and

error messages, Confirmation of appropriated power failure responses,

Challenging system security testing multi-users access, testing

communications reliability between the computer and interfaced system,

testing backup and recovery procedures.

. Recommend corrective actions provide security of the PC's connected to

the laboratory equipment.

. Coordinates meetings and assure all CSV validation activities established

are completed at the time requested such as: Requirements Specification,

Design Specification, Test Summary Reports, Pre/Post Executed Test

methods, and Traceability Matrix.

. Develop Laboratory Equipment Classification such as:

o Equipment System Identification

o Equipment System Description

o Intended Use Classification

o Equipment System Requirements

o Validation Requirements

o Definition and Acronyms

Wyeth, Carolina, PR

2005

Project Manager CSV/ 21CFR Part 11 Requirements

. Performed Validation Plans, User Requirements Specification {URS} and

Functional Requirements Specification {FRS}. Install and qualify CSV to

Micro and Chemistry Lab.

. Designed test plans and execute {IQ}, {OQ} and {PQ} protocols,

Traceability Matrix and Final Report.

. Wrote technical SOPs and provide security of the PC's connected to the

laboratory equipment

. Maintain close communication with the team members to keep apprised of

computerized system needs, impacts on computer validation, and other

relevant issues.

. Follow SOPs and industry best practice to meet the acceptance criteria

and conduct training on good documentation and good testing practices

. Train validation personnel and others on current validation techniques

and processes.

. Developed and challenge Test Methods {IQ} Installation Qualification such

as:

o Documentation verification Test

o Training Verification Test

o SOPs Verification Test

o Utilities Verification Test

o Calibration Preventive Maintenance and Spare Parts Verification

Test

o Environmental Conditions Verification Test

o Hardware Installation Verification Test

o Software review Verification Test

o Physical Security Verification Test

o Directory Structure Verification Test

o Software Backup and Version Verification Test

Reinaldo Cruz

Mobile 787-***-**** accshn@r.postjobfree.com

PROFESSIONAL EXPERIENCE

Wyeth, Carolina, PR (Continue)

2005

. Developed and challenge Test Methods {OQ} Operation Qualification such

as:

o Application Security Verification Test

o Operating System Security Verification test

o Screen Saver Security Verification Test

o Application Time Out Period verification Test

o Screen Navigation Verification Test

o Logical Security Verification Test

o System Log-In Log Verification Test

o Communication Failure Verification Test

o Loss of Power Verification Test

o Data Backup and Restore Verification Test

o Radio Frequency & Electromagnetic Interference Verification Test

o Alarms Verification Test

Pfizer, Caguas, PR

2004

Product Disposition & Change Control Consultant

Reviews batch records for proper documentation and assure they are in

accordance with in process and evaluation forms, Identifies deviations and

request corrections, assign expiration date for packaging products, as

established for each container/closure style, reviews certificate of

Analysis CoA, assure stability samples are taken as per Marketed Stability

Program.

. Evaluate the impact that proposed changes will have on products,

processes, facilities, utilities, to ensure risk minimization and ongoing

regulatory compliance.

Pliva, East Hanover, NJ

2004

Senior QA

. Created & Revised Methods and Specification to R&D

. Created SOP's for new product

. Knowledge of title 21 CFR Part 11 code of Federal Regulation.

. Develop Validation Plans, User requirements Specification {URS} and

Functional Requirements Specification (FRS).

. Designed and executed {IQ}, {OQ}

Watson Laboratories, Miami, FL

2002-2003

Senior QA

. Create and maintain an audit schedule for document Files and Binders.

Performed document-training record. Verified technical data for

Production, such as sterilizer Cycle Printouts and Equipment Logs and

Batch Records.

Reinaldo Cruz

Mobile 787-***-****

accshn@r.postjobfree.com

PROFESSIONAL EXPERIENCE

Eli Lilly, Carolina, PR

2001

Senior QA

. Verified batch records and environmental data were generated in

manufacturing areas.

. Provide services to maintain and control Master Record Documents.

Environmental Technician

. Performed manifest of non-hazardous waste material for

destroyed out of plant and continuous tracking system.

. Created monthly reports such as: DEA 41 and DEA 222 forms

to control substance.

Amgen Pharmaceuticals, Juncos, PR

2000

QC Laboratory Technician

. Performed analysis using different equipment such: as analytical

balances, TOC, buffer preparation, ph and conductivity meter.

. Perform calculation and dilution.

. Responsible for assembling and disassembling processing equipment,

maintain all data generated in the global Laboratory Information

Management System or LIMS.

. Lead the PH test in the Lab. to new water system and work closed with

team member of Validation Department to coordinated and assures the

process of sampling plan for integrity test.

Warner-Lambert, Inc., Fajardo, PR

1998 to 1999

Environmental Technician

. Created and updated standard Operating Procedures taking

into account environmental considerations to comply with

Local and State Agencies, laws and company policies.

. Coordinated meeting with external contractors thus giving

extra support and feedback to our environmental guidelines.

. Revised and created environmental statements to the job

description for assure a safe place to the employee.

Alcon Labs, Humacao, PR

1992-1997

Senior QA

. Prepare and operate Batch Optimization tank according to SOP`s

. Set-up sterilization components and process equipment

. Monitor and adjust sterilization tank

. Verified the weight and preparation of chemicals to be used in

formulation

. Verified environmental data

. Performed Filter integrity test

. Performed sampling tank in aseptic area

. Performed routine assay in formulation and filling areas such as: LAL,

Touch Plate, Rodac, SAP, Swabs, Particles test

. Prepare thermocouple to be installed in formulation tank, sterile line

and autoclave.

Reinaldo Cruz

Mobile 787-***-****

accshn@r.postjobfree.com

SKILLS

. Knowledge of Computer System Development Life Cycle {SDLF}

. Initiative, versatility, and ability to learn new area quickly

. Proven leadership, quality, and management skills?

. Proven record of solving problem independently?

. Productive and efficient work habits?

. Excellent communication and interpersonal skills?

. Ability to prioritize and self manage

. Expert in GLP/GMP requirements

EDUCATION

Interamerican University of Puerto Rico, San Juan, Puerto Rico

. B.S. Microbiology

CERTIFICATIONS

. American Society for Quality Control {ASQC} by Alcon

1996

. Document Lifecycle Administration by Wyeth

2008

. Infrastructure Installation Testing by Wyeth

2008

. Infrastructure Protocol Creation by Wyeth

2008

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