Quality Assurance Manager

ELISA H. PERDON

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

Address: Chattanooga TN 37405 and Acworth GA 30101

Contact Nos. (Cell Phone) 423-***-****

PROFESSIONAL SUMMARY

. Over 30 years experience of managing drugs, medical devices,

cosmetics and veterinary products' quality assurance, regulatory

affairs and production.

. Responsible for the company's compliance to all regulatory

requirements, complaint handling, annual product reviews, product

stability studies, documentation control, quality systems auditing,

CAPA implementation and monitoring, validation of equipment

cleaning, processes and test methods and managing the entire

Quality Department.

. Extensive experience on technically managing Contract Manufacturers

(both domestic and international), product manufacturing site

transfers and quality auditing Contract Manufacturers and reviewing

and approving batches produced by them.

. Responsible for conducting cGMP, Productivity Improvement, Total

Quality Management, Hazardous Waste Management and Oliver Wight

Class A Business Excellence trainings.

. Broad experience on internal/external compliance auditing to

qualify and ensure that the in-house operation, Contract

Manufacturers, Contract Laboratories and Material Suppliers were

complying with the 21 CFR 210, 211, 11, 111 and 820, FDA Q7A, ICH-

Q1A (R2) Drug Product Stability guidelines.

. Responsible for attending to FDA inspections and submitting

responses to audit observations until satisfactorily completed.

. Formulator of OTC Drugs, Cosmetics, Veterinary Drugs and non-

regulated consumer products.

. Key contributor on successful completion of projects by strategic

planning, providing rigid quality assessment of contract suppliers,

product formula development, product and material specifications,

test method development, validation and stability requirements and

standard operating procedures.

. Bilingual (English and Tagalog) - good written and oral

communication skills, computer literate and multi-task oriented.

PROFESSIONAL EXPERIENCE

Shionogi Pharma Inc., Alpharetta GA April 18, 2011 - June 3, 2011

Product Quality Assessment Specialist

. Conduct investigations and risk analysis of contract manufacturers'

discrepancies, non-conformance and deviations to policies and

procedures, out of specifications and out of trend test results and

evaluate /recommend corrective and preventive actions.

Summit Industries, Inc., Marietta GA June 2008

to March 7, 2011

Director of Quality

. General Departmental Functions -

o Headed the Quality/Technical Department (Supervisory) by

managing and assigning tasks and duties of 5 Quality staff

members, reviewed their performances, created staff

development plans and managed the operating expense of the

department.

. Regulatory and Quality Assurance Functions -

o Responsible for the full compliance to regulatory

requirements of pharmaceutical products manufactured and sold

by Summit Industries by keeping abreast on latest amendments

to FDA regulations and CHPA's news releases and attending to

FDA inspections

o Reviewed trends of product data, stability data, out of

specification/out of trend investigations, deviations, change

controls and customer complaints.

o Managed the proper implementation of customer complaint

handling procedures, responding to complaint calls and

emails, reviewing and closing of all regulated products'

customer complaints after full evaluation and effective CAPAs

were implemented; Reported via the FDA Medwatch Form 3500 any

qualified medical adverse complaints; Reviewed with the

President and CEO all serious medical adverse complaints and

trends.

o Responsible for the Annual Product Reviews with top

management (President and CEO, Executive VP, Board of

Directors and Director of Production)

o Ensured proper implementation of validation programs

(prepares/review protocols, its execution, analysis and final

report)

o Ensured on-time instrument calibration and maintenance of

calibration records of equipment and facilities.

o Responsible for developing, reviewing and approving standard

operating procedures (SOPs), validation protocols and

reports, Summit Industries Analytical Methods (SIAMs),

material specifications (raw and packaging materials),

product specifications and batch records

o Conducted internal and external quality compliance audits

and monitored the effective completion of corrective and

preventive actions.

o Responsible for ensuring that product labels were in

compliance with the FDA Labeling Standards.

o Responsible for submitting all OTC Drug Products to the FDA

Drug Listing.

o Conducted the regular cGMP Training of Plant Personnel.

. Product Development

o Provided technical support to new products' planning and

development

o Created new OTC drugs, cosmetics, veterinary and non-

regulated product formulas for Summit and other distributor

clients, conducting ingredient analysis and applications, lab

trials and stability studies

o Coordinated the product technical transfer from in-house

production to contract manufacturing or vice-versa.

. Quality Control

o Ensured compliance to Good Laboratory Practices, OSHA safety

rules and EPA requirements on proper Hazardous Waste

Management

o Maintained the QC staff updated on latest compendial and

testing requirements and be current on industry trends

o Maintained good documentation control of product technical

documents

o Development and/or selection of test methods for various raw

materials and new products.

Chattem Inc., Chattanooga, Tennessee January 2004 to June 2008

QA Manager for Contract Manufacturing

. Provided technical support to International Contract Manufacturers

based in Latin America, Europe, Canada and Asia for the smooth

transfer of Selsun Manufacturing technology from Abbott to

Chattem's hired Contract Manufacturers

. Responsible for the review and final approval of product batches

manufactured by Contract Manufacturers and investigation of out of

specifications (OOS) results

. Lead Auditor of the internal quality audit team conducting regular

audits of the manufacturing and QA operations of Chattem main plant

to ensure adherence to the 21 CFR Part, 210, 211 and 820 -Medical

Devices Regulations and cGMP Regulations applicable to Drugs and

Dietary Supplements; A regular audit of the Consumer Affairs

Handling of Complaints is one of the main focal point of the

internal audit to ensure proper handling of consumer complaints

were in accordance with the SOP on Processing and Implementing

Resolutions to Consumer Complaints; Conducted periodic auditing of

the Infomed Database of Consumer Complaints.

. Conducted Quality Audit of 30 Contract Manufacturers, Contract

Laboratories and compliance audit of API Suppliers to FDA Q7A

Guidelines (including assessment of new Contract Manufacturer's

qualification to manufacture Chattem products)

. Prepared and finalized Quality Agreements with Contract

Manufacturers and Contract Laboratories

. Monitored the CAPA implementation and its effectiveness measurement

. Reported CAPA updates to the Quarterly Management Review as part of

the Quality Systems Management

. Provided technical assistance to Product Supply, Product

Development, Purchasing and Technical Services Groups in the

development of new products and assessment/ qualification of

prospective Contract Manufacturers

. Provided technical assistance to International Regulatory in order

to comply with EU/EMEA, Health Canada, Digemid, Invima, TGA

requirements related to product registration, material source

qualification and manufacturing site registration (includes

monitoring of submission of QAR - Quality Assurance Report and QAQ

(Quality Assurance Person Qualification), FDA Form 482 and EIR,

Site Master Files of contract manufacturers and updating of Chattem

US Site Reference File for submission to Health Canada)

. Prepared/updated QA SOPs related to contract manufacturing and

quality auditing

. Prepared, scheduled and executed the Yearly Audit Plan for Contract

Manufacturers and API Suppliers

. Designed audit checklists for API Suppliers, Contract Manufacturers

and Contract Laboratories

. Prepared Material and Product Specifications for Contract

Manufacturer and ensure that all Product Technical Documentations

are updated

. Ensured up-to-date submission and review of the Stability Reports

from International Selsun Contract Manufacturers

Abbott Laboratories, Mandaluyong City, Philippines Oct 1983 to Dec 2003

Third Party Pharmaceutical Manufacturing Coordinator July 1999 to

Dec 2003

. Qualification of new contract manufacturers to manufacture, test

and package products in accordance with cGMP and Abbott's quality

standards

. Responsible for negotiating with Contract Manufacturer for

reasonable toll fees and ensured that finalized all-in fees were

within the established Standard Unit Cost

. Provided QA and Production processes' technical support to Contract

Manufacturers

. Ensured on-time delivery of drug products and compliance to the

Supply Agreement by the 3 Contract Manufacturers

. Developed new products' packaging designs and specifications for

packaging materials

. Provided inputs to the Finance Department towards negotiating for

reasonable contract manufacturers' toll fees and testing charges

. Headed the Purchasing and Supply Task Team of the Oliver Wight

Class A Business Excellence Certification Program with the

responsibility of reviewing current processes, designing and

implementing process changes and creating strategies to improve

cost, quality, delivery lead time and customer services and

documenting the changes.

. Prepared policies and procedures related to Supply Chain Operations

and Contract Manufacturing

. Designed and implemented the Purchasing and Supply Strategy for

Supply Chain Operations that included Supply Agreement, Purchasing

Policies and Procedures, Continuous Improvement Programs Involving

Suppliers,

. Conducted business cascades and training on Total Quality

Management, cGMP, and Oliver Wight Class A Business Excellence

Program

. Managed projects, prepared timelines, milestones, presented project

proposals and reported their progress to Top Management.

. Received a Chairman's Award for effectively and successfully

managing the smooth transition of closing down the in-house

production plant on-time and saving $7mm on manufacturing costs

while developing three (3) local Contract Manufacturers to

manufacture Abbott products.

. Gained 20% savings on labor and overhead cost for outsourcing the

re-labeling/redressing of various Abbott imported products.

. Consistent on-time launches of new products through strategic

planning of production

Pharmaceutical Products Production Manager Jan 1994 -July 1999

. Managed the manufacturing and packaging operations of

pharmaceutical oral solid, oral liquid, ophthalmic solutions, large

and small volume intravenous fluids and volatile anesthesia and

anti-epileptic products supplied locally and exported to Asian

Countries.

. Prepared operational expense budgets, monitored actual

manufacturing expenditures and reported manufacturing cost

variances versus standard unit costs

. Managed the entire Production Staff composed of 3 Production

Supervisors, 12 Compounders, 2 Engineering Mechanics, 13 Machine

Setters and Operators, 12 Line Operators

. Trained and certified staff on cGMP, Standard Operating Procedures

and designed Employee Training and Development Programs

. Prepared new and updated existing Manufacturing/Packaging SOPs

. Conducted project reviews and recommendations for capital

expenditure allocation, facility and equipment upgrade including

identification and financial justification of requirements,

timelines and progress reports

. Qualified vendor/suppliers to evaluate their processes, controls

and capacities as part of the Suppliers' Accreditation Program

. Assessed staff members' performance periodically to identify areas

for improvement and growth development.

. Obtained 10-25% savings on overall manufacturing cost and achieving

65% margin of locally manufactured products and consistently

providing on-time and full delivery of goods

. Improved cGMP awareness and compliance of the manufacturing

facility.

. Improved productivity of the manufacturing facility by 15%

consistently each year

cGMP/Manufacturing QA/Incoming Materials QA Manager Nov1983 - Dec 1994

. Conducted internal audits of the Manufacturing and QA operations to

ensure compliance to Abbott Quality and cGMP standards and

monitored the CAPA implementation.

. Conducted cGMP training of Production and QA Staff

. Ensured that all major manufacturing and QA activities were covered

by current and/or updated Standard Operating Procedures

. Supervised 6 Manufacturing QA Inspectors conducting the in-process

testing and inspections, line clearances, batch record review and

final batch releases in coordination with other QA sections

performing the chemical, biological and physical controls of each

lot produced

. Ensured that all production lines and activities are in compliance

with cGMP.

. Prepared and updated material specifications, test methods and

procedures for all packaging materials (primary, secondary and

printed materials)

. Achievements - Gained recognition for initiating the cGMP Awareness

Program and Quality Circle in the entire company

Organon Philippines Inc., Makati City Oct 1982 -

Oct 1983

Company Pharmacist and Contract Manufacturing Coordinator

. Key contact person in-charge of coordinating with Contract

Manufacturers for material requirements, toll fee management,

production, QA releasing of materials, bulk and finished goods and

their delivery schedules

. Acted as Regulatory Affairs Liaison Officer for Company Licenses

and Product Registration with the Bureau of Food and Drugs (BFAD),

Dangerous Drug Board and other regulatory requirements

. Responsible for the demand management and stock replenishment

planning and ordering.

National Food Authority /Food Terminal Inc., Manila Apr 1981- Jan 1982

Supervising Pharmacist & Procurement Officer

. Liaised with BFAD (Bureau of Food and Drugs) for the License to

Operate Retail Drugstores

. Managed the Sixteen (16) Retail Drugstore Outlets within Metro

Manila and Suburbs with 52 staff members. Trained them on

merchandising, customer relations, inventory control, replenishment

and sales reporting.

American Hospital Supply Philippines Inc., Makati City Apr 1978 - Apr

1981

Production Supervisor of Harleco and Pharmaceutical Products Division

. Supervised the manufacturing and packaging of AHS Pharmaceutical

and Diagnostic Reagent Products with 6 staff members.

Colgate-Palmolive Philippines Inc., Makati City Apr 1976- Apr 1978

Company Pharmacist and Secretary

. Regulatory Officer for Colgate Kendall Division, in charge of

acquiring Product Registration and Licensure to Operate as Drug

Manufacturer and Distributor

. Performed secretarial functions to the Internal Auditors and MIS

group.

Philippine Women's University, Manila Apr 1974 - Apr 1975

College Professor and Research Assistant

. Taught Pharmacy Major Subjects such as Pharmacy Dispensing,

Pharmacognosy, Pharmacy Latin and Advance Compounding while taking

up my Master's Degree in Pharmaceutical Sciences (averaging to 30

students per class)

. Conducted research works on various medicinal plant derivatives

under the supervision of the Director of Natural Science Research

Center

EDUCATION

Post Graduate work towards MS Pharmaceutical Science (1975 - 1981)

Bachelor of Science in Pharmacy, 1969 - 1974

Philippine Women's University, Manila

SEMINARS/CONFERENCES ATTENDED IN THE UNITED STATES

. June 8 - 9, 2006 - Quality Auditing conducted by Mr. Leonard

Steinborn of AAC Consulting Group, Inc. held at Chattem Inc,

Chattanooga, Tennessee

. April 20,2006 - Requirements, Guidance and Principles for Internal

Audits

. Conducted by Mr. Larry Whittington and sponsored by RAPS

(Regulatory Affairs Professional Society) held at McCormick &

Schmick's Restaurant, Atlanta, GA

. July 25 - 27, 2005 - 7th Annual FDA and the Current Challenges of

cGMPs Conference sponsored by Pharma Conference and the University

of Rhode Island College of Pharmacy held at Hyatt New Brunswick

Hotel, New Jersey

. June 8 - 10, 2005 - Regulatory Path for Medical Devices Training

Course conducted by the Drug Information Association (DIA) Center

for Career & Professional Development and University of Southern

California (USC) College of Pharmacy held in Los Angeles,

California.

. April 12 - 13, 2005 - Quality Systems Regulations and Inspection

Technique conducted by Mr. Leonard Steinborn of AAC Consulting

Group, Inc. held at Chattem Inc, Chattanooga, Tennessee

OTHER SKILLS

. Bilingual - Fluent in English and Tagalog (Philippine National

Language) both oral and written communications

. Computer literate - Microsoft Access 2007, Windows 2003 and XP and

Internet Access, proficient in Microsoft Word, Microsoft Outlook,

Excel, Power Point and Database programs. Can easily adapt to any

computer programs applicable to the job assumed.

. High proficiency in composing various business correspondences,

response to FDA audit, SOPs, Technical Reports Supply and Quality

Agreements, project timetables and progress reports and strategic

plans.

. Very good typing proficiency

. Can independently travel to US domestic and international countries

. Good driving skills (have been driving since 1974 both Manual and

Automatic Driven Cars and Vans)

PROFESSIONAL ASSOCIATION MEMBERSHIP

. Member, American Society for Quality (currently reviewing for the

CQA exam)

. Member of Philippine Pharmaceutical Manufacturer's Association

. Member of Philippine Association of Pharmacists in the

Pharmaceutical Manufacturing Industry

RECOGNITIONS AND SCHOLASTIC AWARDS

. Chairman's Award, awarded by Abbott Laboratories, Sept. 1999 for

performance excellence in successfully handling the smooth

transition of shifting all products manufactured in-house to

Contract Manufacturing and ensuring on-time completion of 1 year

stocks' inventory build-up, site transfer and product registration

with BFAD and importing Asian countries' regulatory agencies while

completing the Pilot runs and Stability Testing on the side of the

Contract Manufacturers.

. 1st Place - Philippine Pharmacy Board with a rating of 93.31% -

February 1974

. Outstanding Alumni in Pharmaceutical Science Field awarded by the

Philippine Women's University Alumni Association - 1985

. Philippine Pharmaceutical Association Award for garnering the

highest college academic rating, awarded by the Philippine

Pharmaceutical Association, March 1974.

. Dean's List (Academic Recognition Award) awarded by the Philippine

Women's University for College Students garnering an above- average

grade of 1.75 (equivalent to GPA 3.7) - 1973 - 1974

. Full Scholarship Grant from the Philippine Pharmaceutical

Association awarded to Top Students of the PWU College of Pharmacy

- 1972 - 1973

REFERENCES

Megan McLean

Manager, Analytical Services

Summit Industries Inc.

Tel. # 678-***-****

Michael Franchot

Former President and CEO

Summit Industries Inc.

Tel # 678-***-****

Precious Goduco

Senior Accounting Manager

City of Chattanooga (Mayor's Office)

Tel # 423-***-****

Contact this candidate