Quality Control Assurance

RAMZI W. KOZAL

OBJECTIVE

To direct and lead a quality department within the FDA regulated industries on documentation,

systems set up and enhancements, quality control, quality assurance, internal and external auditing,

regulatory compliance, method validation, calibrations, stability, workflow analysis and efficiency

enhancement projects.

SKILLS

Over 16 years of experience in the quality and compliance areas of the pharmaceutical and dietary

supplement industries.

Excellent interpersonal, leadership, communication, managerial and organization skills.

Familiar with various manufacturing processes, documentation system, SOP’s, cGMP and GLP.

Familiar with 21CFR parts 11, 58, 111 & 211.

Familiar with various monographs and general chapters of USP/NF, EP, other compendium an d

industry standards.

Well versed in many analytical instruments such as HPLC, GC, AA, UV/VIS, FT-IR, NIR, ICP/MS

etc., as well as various other analytical and laboratory techniques.

Experience in various dosage forms such as tablets, capsules, creams and liquids.

Well versed in generation, maintenance and revision of SOPs, specifications, procedures, batch

records, training, OOS investigations, and other documentation systems.

Proficient with common computer software and data acquisition systems.

Goal oriented and skilled at problem solving.

EMPLOYMENT HISTORY

VR LABORATORIES BONITA SPRINGS, FLORIDA March 2012-Current

MANAGER OF QUALITY AND REGULATORY COMPLIANCE

Developed the quality management system (QMS) to describe how the firm follows GMPs and operates

to maintain a state of control. This includes quality objectives, quality policies, standard operation

procedures (SOPs), goals, activities and guidelines for monitoring, reporting and correcting problems,

all subparts of 21CFR 58, 111 & 211 starting with personnel, physical plant and grounds, equipment

and utensils, production and process control system, quality control and quality assurance, requirements

for packaging components and labels, requirements for the master manufacturing record, requirements

for the batch production record, requirements for laboratory operations, requirements for manufacturing

operations, requirements for packaging and labeling operations, holding and distribution, returned

products, product complaints, product recall, adverse event reporting, records and record keeping,

method validation and annual product reviews (APR).

Implemented current Good Manufacturing Practices (cGMP), internal and external GMP auditing

programs, handling and documenting investigations for Out-of-Specification (OOS) results, deviations

and failures, corrective and preventive actions (CAPA) implementation, contract manufacturing and

laboratory auditing program, supplier qualification program and OCM Quality Agreements.

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RAMZI W. KOZAL

Created Master Manufacturing Records (MMRs), Batch Production Records (BPRs) and finished

products specifications for dietary supplements. As well as specifications for raw materials and

packaging components.

Assisted in the design and implementation of a new dietary supplement manufacturing facility which

was built to meet and exceed GMP requirements for building designs.

Designed and Set- up a new QC lab fully equipped with chemistry and microbiology analytical

instruments.

Designed footprints for a new GLP Lab fully equipped with Analytical instruments for the purpose of

method development/validation and for confirmation of R&D methods and experiments.

NBTY NAPLES, FLORIDA March 2011 - February 2012

VITARICH LABORATORIES NAPLES, FLORIDA March 2008 - February 2011.

MANAGER OF QA/QC AND REGULATORY COMPLIANCE

Essential duties and responsibilities – Oversee and manage the daily activities in the QA/QC

departments and regulatory compliance.

Develop and execute quality programs including objectives, policies, Standard Operation Procedures

(SOPs), goals, activities and guidelines for monitoring, reporting and correcting problems.

Implement, administer and adhere to current Good Manufacturing Practices (cGMP), internal GMP

auditing, handling and documenting investigations for Out-of-Specification (OOS) results, deviations

and failures, corrective and Preventive actions (CAPA) implementation, contract manufacturing and

laboratory auditing program, supplier qualification program, developing specifications for raw

materials, finished products, packaging materials and labeling.

Establish and enforce of GMP – required quality systems and related documentation including

organization and personnel, facilities and grounds, manufacturing operations – Master /batch

production records, packaging and labeling operations, equipment set-up, operation, cleaning,

maintenance and calibration.

Handling customer complaints, product recalls, and regulatory inspections.

Perform regulatory label review

Preparation of Supplement Facts Panels and cautionary language

Developing and Heading the safety committee and implementing OSHA standards throughout the

company.

Developed a general HACCP plan to include the seven principals of a HACCP system.

Company liaison for regulatory agencies, such as FDA, OSHA and DEA

Responsible for review and approval of the Master Manufacturing Record (MMR)

Responsible for review and approval of completed production batch records

Responsible for manufacturing and packaging in-process QA activities

Responsible for review and approval of lab testing.

Obtained NSF’s GMP & GMP FOR SPORT certifications.

Obtained NPA’s GMP certification.

Obtained KOSHER certification from OU.

Obtained ORGANIC certification from QCS.

Possess proven leadership and organizational skills.

Detail oriented and has strong oral and written communication skills.

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RAMZI W. KOZAL

Possess the ability to work with a diverse group of people in a fast paced, constantly changing

environment.

Committed to continuous improvement and learning.

Skilled in technical writing, database management and records retention.

Leadership skills and ability to develop effective working relationship with external and internal

customers.

KV PHARMACEUTICAL SAINT LOUIS, MO 2002-2008

QUALITY CONTROL SUPERVISOR

Primary responsibilities – Supervise the daily QC operation by overseeing testing, reviewing test results

and distributing release information. Oversee the Laboratory for GMP/GLP and safety compliance.

Interface with other departments regarding QC testing information as necessary.

Essential job functions – Supervise the shift analysts by overseeing testing, progress of samples for

release and ensuring assigned tasks are performed. Perform analysis on raw materials, in process &

finished products and stabilities in accordance to 21CFR part 211.

Follow up on assigned samples for testing based on communicated priorities. Oversee the training of new

analysts or new training for current analysts as needed. Perform annual performance reviews for analysts.

Review test data for compliance with cGMP/GLP.

Initiate and direct OOS/OOT investigations within the laboratory as required. Verify the information on

the release sheet for accuracy and distribute to the appropriate personnel. Generate status and backlog

reports and distribute to the appropriate personnel.

Write and update compendia and non-compendia methods for use by the analysts for sample testing. Log

samples into the tracking system for new receipts and retest samples. Verify and release samples in the

tracking system and print a certificate of analysis.

Participate in the introduction of new methodology and equipment into the Analytical Laboratory.

Organize and conduct quality training programs (monthly cGMP)

Conduct internal bi- annual GMP audits.

Review specifications, testing procedures and SOP changes to ensure compliance with cGMP and other

quality policies.

Makes recommendations to hire, discipline members of the department. Perform annual evaluations and

recommends personnel for promotion/demotion as appropriate.

Raw Materials analysis. Full USP/EP/JP monographs.

In process & finished products analysis.

GC & GC/MS analysis of organic volatile impurities and related solvents. Shimadzu, Perkin Elmer and

Varian systems. Packed and capillary columns.

KV PHARMACEUTICAL SAINT LOUIS, MO 2000-2002

QUALITY CONTROL ANALYST

Analytical testing of APIs (raw materials and finished products) through the application of liquid and gas

chromatography. (Reversed & Normal phases; Packed and Capillary columns).

Development and validation of HPLC methods for Vitamin A Palmitate and method Transfers.

The application of various wet chemistry techniques according to the USP, EP, FCC compendia and

internally developed methods.

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RAMZI W. KOZAL

MONSANTO SAINT LOUIS, MO 1999-2000

ANALYTICAL CHEMIST (Agricultural department)

Research support through the application of HPLC Ion Chromatography.

Assistance of several researchers in the development and validation of new analytical methods.

Analysis of routine samples through the application of HPLC according to Non-GLP guidelines for

research purposes. (Roundup weed killer research program)

CELSIS LABORATORY GROUP SAINT LOUIS, MO 1997-1999

ANALYTICAL CHEMIST

HPLC analysis of APIs and excipients (raw materials and finished products) in a GLP laboratory.

Wet chemistry testing of APIs according to the USP, EP, BP and FCC guidelines

Chemical Hygiene Officer.

EDUCATION

Southern Illinois University. Carbondale, IL 1995-1997

Bachelors in Science - Chemistry

Southeastern Illinois College. Harrisburg, IL 1992-1995

Associates in Science – Chemistry

RELATED TRAINING

Yellow belt in six sigma while employed by KV Pharmaceutical.

Completed 5S program while employed by KV Pharmaceutical.

Continuous improvement classes to help define, measure, analyze, improve and control processes and

products while at KV Pharmaceutical.

NSF-DBA course SOPs and Record Keeping for Compliance with 21 CFR Part 111.

NSF-DBA course Good Manufacturing Practices for Dietary Supplements.

Attended numerous GMP & Leadership seminars.

Awarded Who’s Who among students in American Junior Colleges in recognition of outstanding merit

and accomplishments as a student.

For Additional information or references, please contact me at:

Cell: 239-***-****

Email: ******@*****.***

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