Quality Control
Resume:
Huong NGUYEN
Phone: 949-***-****
Email: acy3g6@r.postjobfree.com
Permanent resident
PROFILE
I was Medical Writer at Sanofi Pharmaceutical Company(France).
I am keen to follow a career in pharmaceutical companies, especially in QA and QC Documentation.
I have strong experience in the diabetic narrative writing and review for accuracy and overall consistency of clinical submission documents (CSRs, narratives) at Sanofi to the FDA, EMA, Canada and Japan, preparation of quality documents, SOPs, follow and report the Quality indicators, audit planning and batch files control in manufacturing.
I have scientific and medical background, regulatory knowledge in Clinical trial, pharmacy and quality-ICH, GCP, GMP, ISO 9001, ISO 13485.
I have many transverse skills:
-Flexibility and ability to adapt
-Capacity to work in international teams in different sites
-Respect of timelines
-Attention to detail
-Good team player
I am well-organised, highly motivated and have “want-can-do” attitude, excellent communication skills. In addition, I am reliable and quick to learn.
PROFESSIONAL EXPERIENCE
December 2016- now
May 2016- September 2016
September 2012- December 2012
Dec 2008- Mai 2009
Legal assistant-Immigration law firm, Nguyen &Luu Law office, LLP- Irvine –CA-USA
Write declarations, collect supporting documents for RFE, constitute and check waiver
for denied cases to submit to USCIS
Dental Technician- Classic Dental Laboratory- Tulsa- OK-USA
Medical writer- Sanofi R&D – Department Clinical Documentation- Chillly- Mazarin- France (91)
Write the narratives and review of scientific content and overall consistency of clinical submission documents (narratives, Clinical Study Reports (CSRs)) for submission to FDA, EMA and Canada
Quality Control Documentation Specialist- Sanofi-Aventis R&D – Department Clinical Documentation- Chilly- Mazarin- France (91)
Review of scientific content and overall consistency of clinical submission documents (narratives, Clinical Study Reports (CSRs)) to FDA.
Rewrite narratives in selecting the most significant SAEs and AEs to report
Deal with Quality Control Specialist (QCS) team and other Medical Writers in international and national/ monthly international team teleconference
Set up departmental procedures/ checklists/trending/tracking for the review of clinical documents
Jun 2008- Dec 2008
Feb 2011- August 2011
CRA - Boston Children Hospital and Henri Mondor Hospital- Créteil-France (94)
Regulatory knowledge-ICH, GCP, EU Directive
Methodology for Clinical research
Screening, collection of data on CRFs, data entry verification and validation, answer to queries, collect and shipment of blood samples and CRFs from France to US
Interface between American sponsor and French investigators
Jun 2006- Jan 2007
Quality Assistant – Brenntag -France (77)
Set up Specification Forms, data verification and validation to respond to customers’ requirements
Preparation of Quality documents for audit
Quality Control in laboratory
Mar 2005- Nov 2005
Quality Correspondent - Septodont - Saint – Maur-France(94)
Physicochemical laboratory: CE, HPLC, GC, LC-MS
Batch files’ control
Knowledge of regulatory aspects relating to pharmacy (GCP, GMP)
Writing of Technical File for CE label
Preparation of quality documents: Quality manual, CAPA, Quality Indicators, PPP, SOPs and audit planning : ISO 9001, ISO 13485, ISO 24234
Deal with customers to insure timelines
Records management
QC training of operators
GPAO for stock management
Apr 2004- Jul 2004
Quality Trainee – La Francilienne clinic - Pontault – Combault-France (77)
Managing of patients’ satisfaction data and suggesting CAPA
Jan 2003- Jul 2003
Quality Manager - UFO - Paris - France (75)
Preparation of quality documents: Quality manual, Quality indicators, SOPs for ISO 9001 certification
Jun 2002- Sep 2002
Quality Assistant - Maison Blanche Hospital- Neuilly sur Marne-France (93)
Records management
Publishing of Quality letter
Apr 2001- Jul 2001
Quality Trainee - Pixys - Suresnes -France(92)
Writing of Quality manual
1999
Quality Control Assistant- Colgate - Palmolive (Vietnam)
QC and process of shampoos, toothpastes
Computer literate
Documentum, Office (Word, Excel, Power Point), Access, Basic, Fortran 77
Languages
English : fluent
French : fluent
Tibetan : fluent
Vietnamese : mother tongue
EDUCATION
2014-2015
2011
2010
2008
Tibetan language – INALCO PARIS- France
Tibetan language - Snowland School – Inde
Certificate IV in TESOL (Teaching English to Speakers of Other Languages) – Brisbane Australia
CRA– For Drug Consulting – Malakoff- France
2004
Quality, Security and Environment Manager - Actions Entreprise – Rungis- France
2001-2002
Engineer Pharmaceutical Technics - CNAM Paris- France
2000-2001
Master Production- Organisation- Quality - University of Evry- France
1999-2000
Engineer Physicochemical method of analysis - CNAM Paris- France
1998-1999
Master of Organic chemistry - University of Orsay- France
Medicine – 6 years in Vietnam
INTERESTS
Classical music (piano playing), ping-pong, meditation
REFEREES (References available upon request)
Mrs. Cornelia Niemann, Head Medical Writer- Clinical Documentation- Sanofi- France
Mr. Carlo Brugnara, Professor, Harvard University
MORE DETAILS
For the ISO 9001 certification
Writing the Quality Manual for an Engineering society (2001) and a Cinematography society (2002)
As Quality Correspondent at Septodont
Physicochemical laboratory: CE, HPLC, GC, LC-MS
Writing of Technical File for CE label
Knowledge of regulatory aspects relating to pharmacy (GCP, GMP, CTD, variations)
Preparation of quality documents: Quality manual, CAPA, Quality Indicators, PPP, SOPs and audit planning: ISO 9001, ISO 13485, ISO 24234
As Quality Control Documentation Specialist- Sanofi-Aventis R&D – Department Clinical Documentation
Review of scientific content and overall consistency of clinical submission documents (narratives, Clinical Study Reports (CSRs)) to FDA.
Rewrite narratives in selecting the most significant SAEs and AEs to report
Set up departmental procedures/ checklists/trending/tracking for the review of clinical documents
It was a replacement of maternity leave and I was among the last Fixed-term contractors at Sanofi.
The company started to restructure and the department R&D recruit no more fixed-term contracts and permanent contracts.
From 2010 to 2011,
I went to Brisbane- Australia to perform my English and obtain the Certificate IV in TESOL (Teaching English to Speakers of Other Languages).
In 2012, as Medical writer in diabetic disease (temporary worker) in the same Department Clinical Documentation at Sanofi R&D
Write the narratives and review of scientific content and overall consistency of clinical submission documents (narratives, Clinical Study Reports (CSRs)) for submission to FDA, EMA and Canada.
At the end of my mission, the medicine has obtained the marketing authorization in Europe.
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