Quality Assurance

Gabriel Figueroa

Parque InterAmericana #**

Guayama PR, 00784

787-***-****, 787-***-****

********.*********@*****.***

Core Responsibilities

. Maintain the company in a state of compliance for local and global

regulatory inspections (FDA, Denmark - EU representative, Brazil,

South Africa, Iraq, Japan).

o Lead inspections, reply to observations and complete all

commitments made during or after the inspections within the

established timeframe. Review reports generated by the

regulatory agencies to assure that any verbal commitments made

by any team member are completed.

. Liaison to global plants in different regions of the world(North

America, South America, Asia, Africa, Australia, Europe, Canada,

Japan, China, etc) for resolution of complaints, data submission, new

markets, new product introduction, new business contracts, and

quality agreements or certifications of cGMP compliance.

. Five year and yearly strategic plan for budget, headcount, cost

reductions, process improvements, capital expenditure, training and

personnel development. Drive business goals.

. Plant quality representative and liaison to corporate and division

business, regulatory, R&D, and quality organizations.

. CAPA representative and plant management review owner

Core Duties

. Supervise five(5) departments

o Quality Operations:

. Incoming inspections and dispositions of raw materials,

inserts and labels, secondary packaging and BOM approvals.

. Supplier quality program: selection/approval, auditing,

improving, material complaints, quarterly performance

rating.

. Packaging area line inspections

o Quality Assurance:

. Product disposition

. CAPA and investigations, commitments closure, plant

metrics

. Documents control of SOPs, Batch records, Policies,

Software

. Company policies implementation into local SOPs

o Quality Control

. Testing and Release of raw materials, intermediate and

finish products, stability and compliant samples

. Methods development and/or methods transfer from the

division R&D labs

. Reagents inventory control, chemical explosive reports,

standards stability program

o Regulatory Compliance

. Internal auditing program

. Stability program

. Product annual reports

. Complaints program

. Data collection, reports and analysis of data for the

division regulatory team's updates or new submissions to

the different global authorities.

. Maintenance of Site Master file

o Validation

. Site Validation Master Plan and five(5) year revalidation

plan and schedule

. Generation, execution, summary reports and approvals of all

IQ/OQ/PQ protocols

. Change Control program management

o Validation(continue)

. Generation/execution of special protocols to support

investigation or CAPA, new components, engineering trials,

process improvements, etc.

Tools Used for day to day execution of the job:

. Sensei and trainer in Lean manufacturing and 6S

o Trained all plant professionals and implemented Lean and 6S in

all quality departments

. Root Cause analysis, FMEA, Pareto analysis, 5Ws, and 3Whys concepts

. Quality Engineering and 6 sigma tools

. Paperless systems: Trackwise (Investigations and CAPA, Change Control,

Commitments), Isotrain (training monitoring and other HR functions),

Pilgrim (complaints management), Calman (calibration program

management). LIMS (Laboratory and Stability program management).

. Standard Work sheets

. Visual controls

. Gemba walks

Core competencies:

. Strategic leader.

. Mentor to direct reports and other levels within the organization.

. Strong communicator at all levels with regulatory bodies, corporate,

division and plant personnel.

. Strong presenter (CEO, Division president, global customers, budget

presentations, etc.).

. Leader by example as per company values and company culture. Be

Ethical.

Experience

Year Position Company Country

Products

. 1996 - 2010 Director Quality Baxter Healthcare Guayama,

PR APIs/FP drugs

. 1992 - 1993 Quality Manager Warner Lambert Fajardo,

PR APIs/FP drugs

. 1986 - 1992 Validation Scientist, Schering Plough Las Piedras,

PR Tablets/drugs

Laboratory Supervisor

. 1981 - 1986 Laboratory Supervisor, Lederle Labs

Carolina,PR SVP/LVP/Penicillin Bench Chemist

Education:

. BS Chemistry Universidad del Sagrado Coraz n Santurce Puerto

Rico

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