Control Quality
Resume:
Juan Antonio Alc zar-Marcial
Reparto Teresita AR-22 39th St., Bayam n, Puerto Rico 00961
*******@*****.***
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
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