Quality Assurance

Lillian Kakidas

***** ******* ***** *****

St. John, Indiana 46373

Residence: 219-***-****

Cell: 219-***-****

E-Mail: abn2yf@r.postjobfree.com

SUMMARY

Senior Consultant with greater than 24 years of quality, compliance,

technical, and operational management experience in pharmaceutical,

biotechnology, and medical device companies ranging from start-ups to

large international companies supporting production of sterile and non-

sterile drug products, API, and medical devices. Over 16 years of

experience in leading quality initiatives and building state-of-the-

art regulatory compliance and quality programs that stress quality

management, quality assurance, quality control, and the use of risk

management tools and specializes in quality management system

implementation, design controls, risk management, equipment

qualification, test method and process validation and supplier audits

and regulatory audit preparation. Extensive experience leading

organizational and departmental initiatives with national and

international customers. Accomplished at forging effective solutions

which are user focused and aligned with business needs. Is an expert

in microbiology and sterilization and has extensive knowledge in CGMP

(21 CFR Parts 210-211, 820, 606), GLP, GDP, ICH, EMA, Canada

guidelines and regulations and ISO standards; familiar with GCP

guidelines and regulations and DEA regulations. Experienced in

project management and trained as green belt in six sigma.

Professional Experience

Oct 2011 - Present

Senior Quality Consultant in the Compliance Practice and

Microbiology Subject Matter Expert - working with fortune 500

international pharmaceutical, biotechnology, and medical device

companies to provide Warning Letter / Consent Decree Remediation

/ Prevention and remediation program management and execution.

. Build Quality Systems; establish quality goals and

metrics; implement strategic quality plans

. Oversee quality development: document systems, customer

complaint handling, regulatory audit preparation and

response, internal audits, validation, metrology, training

programs, batch record review and release, management of

material, component, and product handling for approvals,

releases, quarantines, re-inspections, and rejections,

annual product review

. Create / implement supplier qualification processes and

Quality Agreements

. Create / implement risk management plans/ files and risk

assessments

. Lead product assessment audits

. Perform gap analyses of Quality Implement CAPA programs -

applying six sigma concepts

. Create / implement change control processes

. Develop / review nonconformance systems for deviations,

OOS, investigations, CAPA and other variances

. Oversee validation remediation activities process

validation, analytical and microbial test method

validation, facility qualification and equipment

qualification; prepare validation protocols and reports

. Serve as Microbiology expert

. Act as liaison to FDA

Monosol Rx, Portage, IN

Oct 2010 - Sept 2011

MonoSol Rx is a specialty pharmaceutical company leveraging its

proprietary PharmFilm

technology to deliver drugs in films.

Director of Quality Assurance - Reporting to the Vice President of

Regulatory/Clinical Affairs and Quality Assurance;

As the Senior Quality manager oversees Quality Systems development,

implementation and continuous monitoring and updates as required by

new developments in global regulations, regulatory compliance and

quality related issue management systems including Change Control,

Document System, CAPA, Risk Management, Customer Complaint, Regulatory

Audit preparation and response, Supplier Management, Internal Audits,

Validation, Metrology, Training Program, Batch Record Review and

Release, management of material, component, and product handling for

approvals, releases, quarantines, re-inspections, and rejections.

Responsible for overall quality decisions and ensuring that company's

products comply with the regulations; Acts as the compliance liaison

during external and third party inspections and FDA inspections.

Establishes the corporate quality goals and metrics and created and

implemented strategic quality plans. Assists in guiding R&D

activities to ensure that all quality based deliverables are complaint

with regulatory and quality policies and procedures. Identifies,

provides, and leads the implementation of effective solutions to

quality issues within the company.

. Fostered and facilitated continuous improvement culture and

efforts throughout the organizations.

o Created and implemented an improved change control process

implementing a Change Control Review Board to ensure

regulations, processes and procedures impacted by a change

are addressed appropriately. This process improvement

resulted in expedited approval of changes and increased

ability to assure impacted systems were thoroughly reviewed

and identified.

o Implemented improvements to the nonconformance systems

including deviations, OOS, investigations, CAPA and

variances that may arise in the course of manufacturing.

Implemented an improved and streamlined event monitoring

system which clarified for employees events requiring

documentation, facilitated the documentation process and

included a risk assessment matrix to determine

classification of events.

o Revised OOS process to ensure that investigations meet

current requirements and investigation extend beyond the

laboratory into production when OOS determined to be valid.

o Created Risk Management Plans for each product

o Implemented risk assessment and cross-functional approach

to investigations, problem resolutions, corrective and

preventive actions in close collaborations with

manufacturing, process engineering, and materials

management. Additionally implemented process to verify and

trend corrective actions and ensure effectiveness.

o Created an improved Supplier Qualification Process which

included requirements to establish quality agreements with

suppliers. Created Quality Agreements for raw material

suppliers.

MEDEFIL, inC, Glendale Heights, IL

2008 - 2010

A $10 million US company that develops and manufactures injectable pre-

filled medication in syringes produced using terminal sterilization or

aseptic manufacturing.

Director of Quality Assurance - Reporting directly to the President

and CEO

As the Senior Quality Manager administers and manages the Quality

Systems: Directs Quality Assurance activities including Design

Control, Change Control, Document System, CAPA, Risk Management,

Customer Complaint, Post Market Surveillance, Regulatory Audit

preparation and response, Supplier Audits and Internal Audits,

Validation, Metrology, Batch Record Review and Release, Label

Management; Directs Analytical and Microbiological Quality Control

laboratories; Guides R&D activities to ensure that all quality based

deliverables are complaint with regulatory and quality policies and

procedures. Identifies, provides, and leads the implementation of

effective solutions to quality issues within the company. Assists

in preparation of PMAs, 510K, and 505B2 submissions. Acts as the

compliance liaison during external and third party inspections and

FDA inspections.

. Identified gaps in quality systems and their linkages and implemented

corrective actions; Created a Quality Management Plan as a mechanism

to monitor the corrective actions and verify that all the prescribed

elements (e.g. systems or procedures) of each quality system are

present and robust.

o Identified deficiencies in Design History Files and Design Control and

Risk Management Procedure; Remediated the Design History files,

implemented Design Input and Design Output sections and developed Risk

Management plans for each product which lead to obtaining ISO

certification and CE Mark Registration.

o Identified deficiencies in CAPA system; Implemented new process to

managed non-conformances and corrective actions and preventive actions

and outlined process to ensure that non-conformances were properly

investigated by applying six sigma concepts; implemented process

verify and trend corrective actions and ensure effectiveness.

o Improved Supplier Audit process by outlining a defined system for

selection, approval and monitoring of suppliers and established

requirement for Quality Agreements. Performed assessment of suppliers

per new procedure requirements. Created and implemented Quality

Agreements with distributors, contract laboratories, and vendors to

correct deficiencies and meet FDA commitments. Implemented

statistical sampling approach for packaging components and printed

materials.

o Identified deficiencies in test method validation; Created validation

policy; Implemented procedures for equipment qualification and test

method validation; created a site Master Validation Plan. Prepared

protocols and reports for deficient test methods and managed execution

of test method validations

o Identified deficiencies in laboratory equipment calibration and

implemented new procedures to prevent future deficiencies. Completed

calibration of all equipment and entered equipment into the

calibration program.

o Implemented revisions to test methods to meet new regulatory

requirements; ensured new test methods were validated and implemented;

qualified new contract laboratories contracted to perform specialty

testing; Prepared required validation protocols and reports. Prepared

protocols and reports for on-market product stability studies.

o Implemented process for performing risk analysis and creating risk

plans

. Assisted in preparation of PMA and 510K supplement submissions for new

and existing products by writing portions of the CMC sections,

ensuring all quality deliverables were completed and Device History

File was maintained:

o Prepared reports and managed execution of biocompatibility

assessment

and physicochemical testing of container/closure

o Prepared protocols and reports and managed execution of shipping

studies

o Prepared protocols and reports and managed execution of stability

studies

o Prepared product Risk Management Plans and risk assessments

o Prepared Design Inputs and Outputs

o Oversaw Design Review Meetings

. Managed qualification of new Steam-Air Mixture (SAM) sterilizers;

Developed and validated Steam-Air Mixture (SAM) sterilization

process for prefilled syringes: prepared validation protocols and

reports, and performed and managed validation activities required

for submission; Created related equipment and process standard

operating procedures.

Brogan Pharmaceuticals, Crown Point, IN

2006 - 2008

A start-up company focused on the production and development of radioactive

pharmaceutical products for the use in diagnostic and therapeutic

applications in rare diseases using aseptic manufacturing.

Director of Quality Systems - Reporting directly to the President and

CEO

As a member of the Executive Management Committee provides input for

all company decisions. Provides leadership and direction to the

Quality Systems department which includes: Quality Control, Quality

Assurance, Document Systems, CAPA, Metrology, Validation as well as

R&D. Identifies, provides, and leads the implementation of effective

solutions to quality issues within the company. Assists in preparing

NDA and 505B2 submission and acts as the compliance liaison during FDA

inspections.

. Created and implemented a Quality Policy Manual for Brogan

Pharmaceuticals that defines the policies and procedures used at

Brogan Pharmaceuticals to ensure consistent production of safe

and effective products and to ensure that these activities are

sustainable; authored all associated quality polices and

procedures.

. Prepared Validation Master Plan to outline the validation

responsibilities, approach and requirements for the start-up and

qualification of a new manufacturing facility for the aseptic

manufacture of radioactive parenteral drug products. Oversaw

new facility qualification and wrote and executed qualification

protocols for manufacturing cleanroom suite, microbiological

laboratory and analytical laboratory to prepare facility for FDA

inspection and meet timeline commitments to investors.

. Optimized and validated the following microbial and analytical

test methods in preparation for the 505B2 submission of the

first product, meeting timeline commitments to investors: HPLC

assay for drug product, Sterility test, Endotoxin test,

Antimicrobial Effectiveness test, Microbial Count test,

Microbial Ingress testing, Dye Ingress Testing.

. Prepared and executed additional validations in preparation for

product approval such as Media Fill Validation, Filtration

Validation, and Disinfection Efficacy Testing.

. Implemented Environmental Monitoring Program and oversaw the

validation of an automated nonviable particle count system.

. Prepared Supplier Quality Agreements; Qualified suppliers

including obtaining approval of Supplier Quality Agreements.

ABBOTT LABORATORIES, Abbott Park, ILL

1996 - 2006

A $22 billion global company that discovers, develops, and markets quality

healthcare products and services worldwide.

Quality System Program Manager, Abbott Diagnostic Division

2000 - 2006

Managed quality projects addressing compliance issues dealing with

product design, design history files, product and process controls,

verification and validation, risk management and was a driving force

behind resolving microbial issues and aligning the division with

current industry standards and regulatory requirements. Provided

technical support to domestic and international R&D and manufacturing

sites on microbial issues.

. Assisted with development of Design History files and

preparation of Product Risk Assessments

. Developed and implemented a strategic plan to reassess the

microbial quality of over 200 on-market in-vitro diagnostic

products manufactured in the US and appropriately adjusted the

microbial release specifications for these products utilizing

this data and risk management. The reassessment and change of

the microbial release specifications resulted in improved

product quality and a yearly cost savings to manufacturing of

approximately $7 million. Managed budget of $1.2 million.

o Validated all microbial test methods (Sterility, Microbial

Count testing, Antimicrobial Effectiveness testing) to

ensure test result accuracy and compliance with CGMP

requirements.

o Championed implementation and qualification of new

automated microbial testing technology resulting in reduced

manufacturing process time and the ability to proactively

address microbial failures.

o Designed study to evaluate new and current preservative

systems and established method for selection of effective

preservative systems in product design, reducing R&D cost

annually by $150,000.

o Implemented procedures for evaluation of the microbial

quality of new products in the design phase. Established

procedures for translating design input data into

appropriate, cost effective microbial product and process

controls required to manufacture devices under CGMP.

o Implemented microbial process control and identified

critical control points which resulted in a reduction of

non-quality added testing. Performed risk analysis to

support changes.

o Assisted in preparation of 510K supplement submission for

approval of changes

Laboratory Manager, Specialty Products Division

1996 - 2000 Managed microbiology and analytical

laboratories supporting large scale fermentation

manufacture of pharmaceutical API's and agricultural

products.

. Established CGMP laboratories by validating test

methods and implementing

procedures for documentation and review of test results;

implemented cross training program for analyst.

. Championed development, optimization and validation of new

analytical test methods using HPCL, IC and NIR and automated

microbial test methods to monitor fermentation processes.

. Implemented process controls throughout the fermentation process

resulting in improved ability to monitor each process and

implement and evaluate process improvement steps.

. Reduced manufacturing costs by leading a Fermentation

Harmonization Team across sister divisions that resolved

manufacturing issues involving culture optimization,

optimization and harmonization of test methods used to monitor

fermentations, and reduction of contamination issues.

SOLVAY PHARMACEUTICAL (BAYER PHARMACUETICAL), Elkhart, IN

1988 - 1996

A $6 billion global company that discovers, develops, and markets chemical,

biotech, and pharmaceutical products worldwide.

Project Manager

1993 - 1996

Lead R&D team composed of senior staff scientists and associate

scientists on various projects aimed at optimization of large scale

fermentation for the manufacture of bacterial and fungal enzymes used

in the food and pharmaceutical industry. Served as technical expert

for transfer of new processes to domestic and international sites.

. Developed and managed a screening program for isolation of new

products.

. Successfully engineered new strain capable of producing higher

yields. Developed and optimized fermentation process for new

strain resulting in a 15% increase in fermentation yields.

. Identified cause of assay variability in a product release test

which reduced test variability from 30% to 4%, eliminating

delays in processing and product release.

Fermentation Microbiologist

1988 - 1993

Managed fermentation laboratory and large scale fermentations for the

manufacture of bacterial and fungal enzymes used in the food and

pharmaceutical industry.

. Reduced contamination rate in production by implementing

process control resulting in

an annual cost savings of $200,000 and minimizing distressed

inventory issues.

. Developed microbial process controls for purification of

fermentation products resulting in elimination of addition al

filtration steps and reduced production cost and process time.

. Optimized seed propagation in manufacturing by developing a

defined media resulting in 15% increase in fermentation yield.

. Optimized shake flask media for culture propagation resulting in

10% increase in fermentation yields and consistent process time.

Prior experience includes working as a Supervisor of the Microbiology /

Immunology / Mycology Department in St. Anthony Medical Center, Crown

Point, IN

EDUCATION

MS, Microbiology (Biotechnology - specializing in genetic engineering)

Illinois Institute of Technology, Chicago ILL

Thesis: Conversion of CO2 gas from Waste Streams to Glucose by a

Photosynthetic Microorganism

BS, Microbiology

Purdue University, West Lafayette, IN

Minor: Chemistry

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