Neyssa Almeyda P rez

787-***-**** acfv6k@r.postjobfree.com

(( Quality Systems (( Product & Site Investigations (( Experience in

Manufacturing & Packaging Areas (( Process Optimization ((

Proactive Engineer with over 5 years of intensive experience and proven

capabilities in applying engineering and science based approaches in the

manufacturing and packaging product industry in order to increase product

sustainability, reduce deviations and product complaints while optimizing

overall process capability. Highly flexible and adaptable; committed to

optimizing resources while improving quality. Considered an innovative,

methodical, detail oriented professional; organized, reliable, and highly

committed. Proficient in utilizing investigative tools and techniques to

identify and evaluate the cause of an event including root cause analysis,

Failure Mode and Effect Analysis, corrective and preventative actions and

monitoring effectiveness of implemented actions to comply with the FDA

cGMPs investigation requirements/guidelines amongst others. Vast experience

investigating, documenting and bringing to conclusion the outcome of

product/processing related incidents, deviations or documentation errors

pertaining to manufacturing and packaging, laboratory, finished product,

raw materials, components, product storage/distribution and complaints.

Ability to identify areas of opportunities within operational processes,

while developing plans and actions in order to achieve process

optimization.

Skills

. Technical knowledge in manufacturing and packaging processes,

technologies and processing equipment

. Proficient knowledge of cGMP's, ISO 9001 and FDA regulations

. Knowledgeable and proficient in problem solving skills and statistical

analysis of data

. Effective in organizing work, managing time and planning to achieve

results

. Proficient in negotiation skills and business savvy/awareness

. Proficiency in handling concurrently and effectively multiple high

priority initiatives with evident sense of urgency and sound Quality

minded approach, while maintaining high level of attention to detail

. Proficient in the use of Personal Computers, including knowledge of

Microsoft Office suite and electronic mail applications

. Proficient in electronic inventory control systems (SAP)

. Proficient in electronic Quality Management System (Trackwise)

. Fully bilingual (English and Spanish), both verbal and written with

excellent proven technical writing skills

. Proficient knowledge in product production principles, Process

Optimization, Quality Assurance and product safety.

. Ability to interact with business partners at all levels

. Team player who can handle multiple projects simultaneously in fast

paced environment

. Skilled in Kaizens, Lean Manufacturing and Six Sigma continuous

improvement processes

Professional Experience

Warner Chilcott LLC Fajardo, PR

March 2009-

Present

Process Quality Compliance Engineer (June 2010 - Present)

. Recommend and/or implement changes to safety procedures, work processes,

in order to assure continuous process improvement.

. Responsible for preparing and presenting performance metrics related to

customer complaints and site unplanned deviations.

. Lead and or assist in Cross Functional Teams regarding process

improvements, achieved by corrective actions implemented through site

investigations.

. Utilize process improvement methodologies such as Lean Manufacturing,

Six Sigma & Kaizens in order to establish corrective and preventive

actions while achieving process and product optimization.

. Responsible for thoroughly investigating unplanned deviations related to

facilities, product and production areas, amongst others, by applying

investigative tools and techniques such as FMEA, Cause and Effect

Diagram, Kepner

Neyssa Almeyda P rez

PAGE 2 of 3 acfv6k@r.postjobfree.com

Process Quality Compliance Engineer - Continued

Tregoe (KP), Input-Process-Output (IPO), 5 Why's, in order to obtain the

root cause and establish corrective and preventive actions. Use

investigative tools to perform data analysis in order to evaluate

alternative solutions.

. Conduct, lead and/or participate in project meetings involving project

stakeholders and senior management regarding evaluation and impact

discussions of reported events to ensure that actions are identified to

prevent recurrence.

. Review and evaluate each event under investigation against the

applicable defined/implemented metrics to monitor the effectiveness of

corrective and/or preventive actions and communicate results to site

management.

. Maintain an updated knowledge of the cGMP regulations and FDA Guidelines

and utilize those principles in the investigation process and final

report issuance.

. Perform APR portion related to product unplanned deviations and product

complaints while providing product recommendations in order to assure

that appropriate documented evidence supports the

changes/recommendations and that its effect on product quality can be

either anticipated or mitigated.

. Provide technical support to Area Managers and Supervisors by

recommending improvements in order to maximize equipment effectiveness,

increase manufacturing and packaging capabilities while improving

product quality.

. Provide support in GMP related aspects associated to the

manufacturing/packaging/laboratory processes regarding outcomes,

stemming from investigations, complaints, deviations, CAPAs, change

requests and APRs.

. Develop and implement measures to monitor the effectiveness of the CAPA

systems while partnering with management to develop and implement proper

trending of CAPA performance.

. Participate in the creation, writing, review and revision of product and

areas standard operating procedures in order to assure these are

consistent with current practices, cGMPs, guidelines and policies,

industry practice and trends.

. Serve as the initial point of contact for local plant Product

Complaints, while evaluating possible product risk escalation and

ensures risk assessment is timely and adequately addressed. Perform and

document complaint investigation and assure its timely closure.

. Maintain track and trending of product performance, based on received

complaints for possible escalation to CAPA.

. Participate or lead Cross Functional Investigations (CFIs) involving

Area Managers and Site Leaders, regarding product or equipment failures,

as required.

. Provide training in SOPs related to the QA area to colleagues from other

functional areas, as required.

. Issue investigation reports, complaints follow-up and applicable monthly

monitoring progress reports for the site.

. Apply methodologies or techniques and statistical analysis tools such as

Improvement Models, DMAIC Process and Mistake Proofing in order to

optimize processes.

. Effectively interact with cross functional teams at all levels,

particularly with manufacturing, packaging, Technical Services,

laboratory, Planning/Logistics, HR and Engineering at the site and at

other Warner Chilcott sites in order to identify areas of opportunities

and develop plans in order to achieve higher product quality.

. Evaluates the manufacturing processes with the Technical Services groups

in order to determine improvement possibilities.

. Recommend to management course of action in order to solve problems and

identifies alternatives.

. Identify problem areas processes, and develop proposals for the

improvement of product quality efficiency through process optimization

duties.

. Identify, initiate, lead and or participate in improvement projects that

deliver benefits to any process of the plant.

. Actively participates in the creation and analysis of metrics directed

to define opportunities for improvement and reduction of variation

opportunities.

. Participate in the equipment evaluation process as part of the deviation

reduction initiative in order to optimize efficiencies.

Neyssa Almeyda P rez

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Quality Compliance Specialist (July 2009 - June 2010)

. Evaluated executed batch records vs applicable procedures and analytical

results vs established specifications and provided disposition of lots.

Verified and completed the applicable checklists to ensure

accountability of all applicable documents.

. Coordinated priorities with the Logistics Area in order to assure timely

product release, within determined forecast.

. Wrote and reviewed departmental procedures to assure update with current

practices or cGMPS trends and issued requests of samples as needed.

. Maintained upper management updated regarding any event that might

affect the quality and/or timely release of lots.

. Suggested improvements in the working area related to documentation

design and flow to the supervisor/manager.

. Granted lot disposition in the inventory control system (in-process,

bulk product, finished products and third party lots) while

participating in Cross Functional Investigations (CFls), as needed.

. Reviewed the status, through the inventory control system, of raw

materials and/or packaging components in order to assign disposition

status to manufactured and packaged products.

. Provided training in SOPs related to the QA area to colleagues from

other departments as required.

. Changed SAP status for all raw materials, bulk product, packaged

products and third party lots making sure that all documents are

completed and approved.

. Revised and approved manufactured and packaged product batches in a

regular and timely manner while providing any support needed to the

batch certification experts.

Safety Compliance Specialist (February 2009 - July 2009)

. Audited the Hazardous Product Program (Tooling Rooms, Waste Treatment

Plant and other Engineering Areas), to assure product Material Safety

Data Sheets (MSDS) are maintained and followed by colleagues,

temporaries and contractors while Updating plant SOPs and preventive

maintenance forms and procedures under evaluation.

. Audited the fire system inspection and testing practices and their

records. Conducted special inspections of these systems as requested in

the emergency procedures and preventive maintenance program.

Environmental Resource Management (ERM) Guaynabo, PR

August 2008 - February 2009

Chemical Engineer (Intern)

. Worked directly with the Air Division of various Pharmaceutical and

Manufacturing sites, monitoring their respective LDAR Programs (Leak

Detection and Repair).

. Audited and updated PNID's (Piping and Instrumentation Diagrams) for

various Pharmaceutical Plants.

Education and Training

PUPR, Polytechnic University of Puerto Rico, Hato Rey, PR 2012

Masters in Manufacturing Engineering, Quality Management

PUPR, Polytechnic University of Puerto Rico, Hato Rey, PR 2008

Bachelor of Science, Chemical Engineering

PUPR, Polytechnic University of Puerto Rico, Hato Rey, PR

. Six Sigma Course

. Design and Implementation of Statistical Sampling Plans Course

. Lean Manufacturing Course

Business Excellence Consulting, Inc

. Minitab Course - Applied Statistics

. Certified Quality Engineering Course

Guerra Consulting Group, Inc:

. Failure Investigations: A Workshop Activity for Manufacturing &

Laboratory Operations

Sagrado Coraz n University, Santurce PR:

. PNL: Neuro-linguistic Process Programing Course

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