Juan Antonio Alc zar-Marcial

Reparto Teresita AR-22 39th St., Bayam n, Puerto Rico 00961

787-***-****

accafr@r.postjobfree.com

Summary of Qualifications

Versatile professional with strong experience in Quality and Regulatory

Compliance in the Pharmaceutical Industry. Use SAP and TrackWise to track

site change controls. Experience as Compliance Network member in the

regulatory process, using PDM to verify specific market approval, DocSet

status and document site implementation. Close RANs and process PCPs and

PCRs. Participate of Global supply Meetings with Plant, Regulatory and COQA

representatives. Search for site sponsors for changes initiated by COQA.

Effective in the set-up of priorities and establishing objectives. Able to

make difficult decisions under stressful conditions. Fast learner,

proactive, responsible, flexible and organized. Ability to help others to

learn through trainings and individual courses. Computer literate

Microsoft Office (Excel, Word), SAP and TrackWise. Bilingual in English

and Spanish.

Major Accomplishments

Led transition from manual record management to electronic records

TrackWise Change Control module Implementation

SAP Change Control module Implementation

Led a project to eliminate Backlog/Overdue Change Control documentation and

implement mechanisms to avoid reoccurrence.

Led a multi-site team in the evaluation, design and successful

implementation of a Global Change Control communication system.

Recipient of a PGS Mission Award Recognition (3Q2012) for participation in

the team that developed and implemented Global QTS (Quality Tracking

System).

Recipient of a PGS Mission Award Recognition (3Q2011) for participation in

the team that worked on the reduction of Products Rejected in Fill Level

Inspection Machine #2.

Spoke at the Institute of Validation Technology's Change Control Annual

Conference (2009, 2010, 2011, 2012 and 2013).

Recipient of a Quality and Excellence Global Recognition Best Practice

Award (2007) for participation of the MBR simplification project.

Contribute during product transfer and plant closure.

Professional Experience

New Heaven Reef Conservation Program, Koh Tao, Thailand

Marine Conservation Volunteer

2013

Participate of Coral Reef environmental monitoring program for

invertebrates, fish and subtracts. Perform sea horse and shark surveys.

Monitor the health of coral reefs and identify trends and potential issues.

Monitor diseases and predators. Design, build, install and maintain

artificial reefs. Bio-rock artificial reef maintenance. Collect coral

fragments for coral nurseries. Maintain coral nurseries. Transplant Corals

from the coral nurseries to the artificial reefs. Participate of sea turtle

head start Giant Clams nursery programs. Participate of land and underwater

clean-ups. Participate of activities designed to educate about the

importance of the coral reefs.

Pfizer LLC, Carolina, Puerto Rico

Record management Specialist 2

2003 to 2012

Formerly Wyeth. Review and approve change control documentation for

compliance with cGMP regulations, FDA guidelines and industry standards;

determining if scope, methods and acceptance criteria are appropriate.

Serve as Change Control Coordinator for Parenteral Lyophilized products.

Coordinate and participate in cross-functional meetings to discuss Change

Controls, their impact and requirements. Review Master Batch Records to

comply with approved and validated specifications and proposed change.

Notify all affected that the change has been approved for implementation,

on going, or closed. Identify lots impacted by change controls in the

electronic tracking system and update their release status. Keep

departmental metrics. Provide Change Control information for the Annual

Product Review. Originate and complete Investigations. Approve as a

Quality Representative the Commitments related to the Change Control Area.

Revise the procedure for any significant improvement in quality, compliance

and service. Train personnel in the area procedures and electronic tracking

system. Approve access requests for the electronic tracking tool. Use

TrackWise and SAP to track Change Controls. Serve as Compliance Network

Member in RCCM for changes with regulatory impact. Use PDM and GDMS to

verify specific market approval status. Provide information for regulatory

inspections (FDA, ANVISA, MHRA).

Schering Plough Products LLC. Manati, Puerto Rico.

Change Control Specialist

2002 to 2003

Serve as the Site Change Authorization (CA) Coordinator. Serve as link

between Change Administration (Corporate) and the local Change Control

Area. Perform TrackWise Site Coordinator activities. TrackWise is a CFR

part 11 compliant web based tracking system. Serve as connection between

Worldwide Quality and the site for local modules. Update, prepare, and

train on local procedures for the use of the tracking tool for the Change

Control Area. Assist in the implementation and upgrade of TrackWise

modules. Present upper management metrics on the area's performance in

Quality Council meetings. Represent the Change Control Area in the

Equipment Change Control sub-system. Participate on the reengineering of

the Change Control Area. Revise and update the area's procedures. Train

the site on Change Control Management related procedures. Perform Change

Control Coordinator's responsibilities.

Schering Plough Products LLC. Manati, Puerto Rico.

Change Control Coordinator

2001 to 2002

Review and approve change control documentation for compliance with cGMP

regulations, FDA guidelines and industry standards; determining if scope,

methods and acceptance criteria are appropriate. Evaluate proposed SOP's,

Manufacturing Orders, Procedures, Replacement regulatory documentation

(NDA, NADA, HRD, DMF, VMF) from a regulatory perspective. Ensure that a

Change Authorization is complete, based on a scientifically sound rationale

and has all the documentation to support it. Provide technical support to

the originators in terms of the documentation needed to support a specific

change. Participate in cross-functional teams focused on continuous

improvement to equipment and processes. Notify all signatories that the

change has been approved for implementation, on going, or closed. Assign a

unique tracking number to the change control requests, expedite the change

control package within workflow as well as assembling and archiving

completed packages. Maintain database of changes to support Quality

Metrics, Audits, and Regulatory Submissions. Changes are tracked trough a

CFR part 11 compliant system tool called TrackWise. Provide QC Product

Disposition Department and Statistical area Information regarding any

change in order to release a batch and compile information for the Annual

Product Review.

Ortho-McNeil Pharmaceutical. Manati, Puerto Rico.

GMP Auditor

2000

Perform GMP audits in all areas including packaging, processing and

warehouse to assure compliance of regulations and local procedures. Perform

bio-burden and environmental monitoring sampling, evaluate data for

trending and make recommendations for sampling frequency and procedures,

testing procedures, alert and action levels of microorganisms. Identify,

alert and solve situations that will represent potential GMP or

microbiological issues. Generate first run notices. Perform inspection

based on specific AQL for defects exceeding their alert limit. Documented

the conformance or non-conformance of the audited materials. Approve

templates for printed primary packaging. Train technicians in Self-

inspection program and distribute information about changes of the

specifications. Review batch records for ongoing processes.

Education

Evangelical Seminary of Puerto Rico, Rio Piedras

Master's Degree in Arts and Religion (Magna Cum Laude)

University of Puerto Rico

Bachelor Degree in Natural Sciences, Major in Biology

Certifications

Quality Improvement Associate Certification (CIQA) # 3059

Contact this candidate