Quality Assurance Customer Service

MARIA O' DONOVAN B.Sc. Pg.Dip

Address: Donaskeigh, Tipperary, Co. Tipperary, Ireland

Home Tel: 062-71242 Mobile: 086-******* E-mail: **********@*****.***

Career Aim & Profile:

My ambition is to become an invaluable employee in a USA based

pharmaceutical company. I have extensive experience in GMP controlled

laboratories from working as both a microbiology analyst and QC technician.

In these roles I performed product testing, collected and analysed data,

and reported to the lab managers daily. I worked to improve quality

systems. I have gained a deep understanding of cGMP to date.

Skills:

Regulatory: Broad knowledge of ICH guidelines such as ICHQ7A which

represents the FDA's current thinking on cGMP's for API's, ICHQ8A, ICHQ9A;

CFR 210 and 211 established by the FDA for finished pharmaceuticals; EU

guide to GMP volume 4, Annex 1

Microbiological/ Chemical: Extensive experience of enumeration, pure

culture isolation and removal of bacteria using microbiological techniques.

Also performing environmental monitoring, serial dilutions; aseptic

techniques; plate streaking; and titrations.

Pharmacological, Physiological, Toxicological: Vast knowledge of how drugs

affect the body, side effects, clinical trials from phase I to IV.

Biopharmaceutical Analytical: Experience using EIA, electrophoresis,

chromatography for protein purification.

Quality Assurance; Auditing and Inspection: Knowledge of QMS such as ISO

9000, NCR report writing, CAPA and how to conduct an audit both internally

and externally.

Pharmaceutical Analytical and Method Validation: Experience in obtaining

the content of certain ingredients in drugs such as the amount of

acetylsalicylic acid in aspirin tablets using UV spectroscopy.

Pharmaceutical Manufacturing: Extensive knowledge in relation to the

principle of LEAN manufacturing and, how to read a plant fast.

Pharmaceutical Management: Knowledge on the different styles of management

and how to transmit the information to the receivers.

Cell Culturing: Experience of upstream and downstream processing of

mammalian CHO cells in the UCD facility NIBRT.

Presentations: Extensive experience presenting on topics such as GMP

Validation; pharmaceutical technology such as tablet manufacturing,

pharmaceutical facilities and utilities, general management styles within a

pharmaceutical organisation.

Time Management: Have the ability to meet assignment, presentation and

project deadlines

IT : Microsoft Office, Powerpoint, Internet

Lingual: Knowledge of German to honours Leaving Certificate level

Educational Details:

2010 Pg Dip in Pharmaceutical Quality Assurance and

Biotechnology,

Dublin Institute of Technology

Grade: 2H1

2008 BSc (Hons) Nutritional Sciences, University College Cork

Awards:

2004 Awarded University College Cork academic scholarship

Professional Work Experience:

2008/09 Food Chemistry/Microbiology Analyst

Microchem Laboratories, Dungarvan Co Waterford

. Testing food samples based on GMP

. Operation, maintenance and calibration of lab instruments

. Using ELISA techniques everyday in pathogen lab and subbing food

samples

. Microbial Identification

. Streaking food samples onto plates to discover if bacteria present

2007. Quality Control Technician

Musgraves Supervalu Centra, Tramore Road, Cork

. Routine Quality Control analysis performed.

. Produce was examined for the presence of mould, bruising and

discolouration and results entered on the computer database.

. Product was probed to make sure it was at the correct temperature.

. Non- Conformance Reports as well as claim reports for bad quality

produce were prepared and issued to those concerned.

. Developed excellent communication skills through liasing with

suppliers and customers.

Cashier/Floor Assistant

Longs Drugstore, Pacific Beach, San Diego, CA 92109

. Maintained a high standard of customer service in an American pharmacy

. Responsible for training new staff members

. Assisted customers with queries regarding various medical/nutritive

products in a professional manner

2002. Laboratory Assistant

Tipperary Co-op, Tipperary Town

. Responsible for the microbiological testing of cheese and butter

products for pathogens, which could cause disease.

. Learned the importance of maintaining exact hygiene standards.

. Gained invaluable experience in the laboratories.

Referees:

Referees available on request

Contact this candidate