Manager Project
Resume:
Nelson Cruz Feliciano
Address: PO Box **, Manati, PR 00674 Mobile Phone:
Email: ***.******@*******.***
Summary of Qualifications
Assertive, detail-oriented professional with a background in
chemistry, and vast experience in Quality Operations, Logistics and
Active Pharmaceutical Ingredient Manufacturing. Effective problem-
solving skills and excellent performer under-pressure in fast-paced
environment. Productive leadership skills based on respect,
diplomacy, teamwork, ownership and commitment. Consistent record of
improving processes and documentation controls while ensuring
compliance with cGMPs, and regulatory requirements.
Outstanding Professional Accomplishments
Recipient of 'Distinguished Contributors Award" for outstanding
efforts and dedication in the area of Documentation and Change Control
during the FDA consent decree at Schering-Plough.
Recipient of a special award granted to key Schering-Plough employees
identified as critical to the company in ensuring fulfillment of the
consent decree commitments and in achieving the Company's future
organizational growth objectives.
Led Document Control team to a successful and timely deployment of
four documentation Quality Standards during consent decree at Schering-
Plough.
Professional Experience
GE Healthcare, Waukesha, WI
Global Quality Assurance Leader - Document Control
(2007 - 2009)
Contributed to the efforts of the Global QA team to drive a world-
class quality system across the GE Healthcare organization
Provided leadership in establishing and deploying standard processes
for document development, management and control.
Authored global quality and document control procedures and related
training documentation.
Developed requirements for standardization and consistency of global
procedures and work instructions.
Reviewed and assisted in preparation of global quality documents prior
to submission to Document Change Authorization Board.
Schering Plough Products, Manat , Puerto Rico
Manager, Site Documentation and Change Control
(2005 - 2006)
Manager, Site Documentation, Quality
Operations (1999 - 2005)
Responsible for the Document Control Facility projects, including the
installation of a Document Control Center, Document Storage Vault and
Records Retention Center.
Managed the Document Control Center and established systems for the
control of site procedures, manufacturing batch sheets and records,
test methods and specification documents, protocols, cGMP registers,
logbooks, and procedural forms.
Responsible for managing the site's Change Control system, through
which changes impacting processes, equipment and facilities were
evaluated, reviewed, approved and archived in compliance with
established Quality Policies, Quality Standards and Site Procedures.
Managed the site's Records Retention Center. Responsible of the
custody, control and security of the site's quality and business
records. Provided an accurate and expedited retrieval service of
documents stored on and off site. Document retention schedules were
closely monitored.
Site Project Manager for the implementation of the Global Electronic
Document Management Systems (GEDMS).
Performed as Quality Team Lead for a 3-year special assignment during
consent decree. Responsible for the execution of the FDA commitments
related to document controls. Prepared and presented Documentation
and Change Control metrics and analysis to the site's Quality Council
and the Consent Decree Senior Management Committee.
Supervised, coached and evaluated the professional development of 10
direct reports, including Laboratory Change Management Supervisor,
Documentation Supervisors, Change Control Coordinator, Change Control
and Documentation Specialists, "Documentum" User Administrator &
Records Retention Administrator.
When required, met with third party and FDA inspectors to discuss
document control processes.
Production Planning & Inventory Control Manager
(1997 - 1999)
Warehouse
Manager
(1996 - 1997)
Managed logistic activities including, generation and analysis of
production plans, master production schedules and inventory planning
and control.
Implemented the Production Module of the site's Planning & Inventory
Control System, PRISM. Trained site system end-users and traveled to
sister plant in Singapore to train Planning department colleagues.
Managed Warehouse Operations. Responsible for the receiving,
handling, storage, weighing, dispatching, of raw materials, primary
and secondary components, Intermediates, Active Pharmaceutical
Ingredients and Finish products.
Chemical Plant Manufacturing
Manager (1993 - 1996)
Netilmicin Plant Manufacturing
Manager (1991 - 1993)
Steroids Plant Manufacturing
Manager (1987 -
1991)
Responsible for providing a quality product in a timely manner while
sustaining compliance with cGMP's, Regulatory, Safety and
Environmental requirements.
Prepared annual budgets, controlled spending, and monitored production
processes and yields to assure that financial goals were met.
Responsible for the supervision, coaching, evaluation and professional
development of direct reports, including Technical Assistants,
Production Plant and Laboratory Supervisors. Average number of direct
and indirect employees per plant was of 26.
Technical
Assistant
(1984 - 1987)
Assisted the plant manager in technical aspects related to the
manufacturing of steroids.
Performed process and equipment troubleshooting; also involved in
technology and process transfer.
Prepared and revised batch records, standard operating procedures,
protocols and bills of materials.
In Process Laboratory
Chemist
(1982 - 1984)
Performed testing and analysis for the Steroids and Netilmicin
Chemical Operations.
Academic Background
University of Puerto Rico
Degree: Bachelor of Science in Chemistry Graduation
date: June 6, 1982
Courses and Seminars
Good Electronic Records Management (GERM) Conference
Trackwise (Investigation Module / Change Control Module)
Basics of Supply Chain Management
Chemical Engineering and Process Fundamentals for Chemists
Kepner Tregoe Problem Solving Workshop
Supply Improvement Process (SIP), Methodology and Tools Training
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