I am looking for a job in the pharmaceutical field based in Mauritius. I have a strong Quality and Regulatory background. I have 10 years experience in the pharmaceutical industry working for GlaxoSmithKline which includes over 3 years in Regulatory Affairs and 3 years in Quality Assurance.
Education History, Qualifications & other additional information:
Level of Education:
Bachelor
1995 – 1998
University of Strathclyde
BSc Hons Forensic and Analytical Chemistry - First Class Honours.
1987-1993 Loreto Convent Quatre-Bornes, Mauritius
A levels: Mathematics (A), Chemistry (B), Physics (B)
Sub level: General Paper (B), French (A)
Additional Information
I speak and write English and French fluently.
I am computer literate, familiar with a range of computer packages and databases (excel, project, power point, LIMS, Lotus Notes, Isis Draw, Documentum, Statistica).
I have gained good presentation skills by giving presentations throughout my university course and at work. I have prepared and conducted a number of training packages to colleagues (for e.g. new ways of working).
Excellent knowledge of regulatory environment (Europe and International)
Good knowledge of various quality standards in particular ICH and pharmacopoeial standards and an appreciation of ISO 9001 standards.
I have gained excellent report writing skills through my various jobs in particularly through my time in the Regulatory Affairs department.
I have a Green Belt in Lean Sigma and therefore have a good understanding of statistics, and have used a number of tools aimed at eliminating waste and improving processes in my current role.
My current employer has identified me as a key talent on the site and is currently putting me through the Leadership and Development Programme that is ran within GSK (in association with ILM – Institute of Leadership and Management).
Work History & Experience:
Years of Work Experience:
10 to 15 Years
I joined GlaxoSmithKline (GSK) in September 1998, straight after graduating from the University of Strathclyde. The following summarises the various roles held both in GSK, Irvine (Scotland) and GSK, Greenford (England).I joined GlaxoSmithKline (GSK) in September 1998, straight after graduating from the University of Strathclyde. The following summarises the various roles held both in GSK, Irvine (Scotland) and GSK, Greenford (England).
September 1998 – February 2000 Development Chemist, GSK Irvine
Mainly laboratory based projects looking at yield improvement and robustness. Most of the laboratory work was carried out on Automated Lab Reactors. During this time I took responsibility for my own analysis and became proficient in wide range of analytical techniques including HPLC and GC.
February 2000 – August 2002 Process Chemist, GSK Irvine
Responsible for making sure the process is running smoothly and addressing day to day issues/problems, writing deviation/failure reports as required, raising technical changes and change controls. Also dealing with the Quality/Regulatory/Environmental/Safety & Purchasing Departments on a regular basis. Carried out supervision & training of placement students and junior staff.
September 2002 – March 2006 Regulatory Executive, GSK Greenford
Regulatory Executive in post approval regulatory affairs (Europe and Rest of the World): Responsible for a portfolio of marketed drug substances. Main responsibilities involved supporting manufacturing sites through the submission of regulatory dossiers. This job helped develop my report writing skills as high quality documents are required to be submitted to the regulatory agencies. High level of interactions within GSK (UK/Europe/International markets) and outside GSK (regulatory agencies).
April 2006 – Present Quality Adviser, GSK Irvine
As part of this role I am the primary Quality contact for a number of processes ran in the Actives plant at Irvine. Main responsibility is the compliant release of material for onward processing off site once manufacture at Irvine is complete. In this role I work closely with the quality control laboratory and ensure analysis takes place in a compliant manner. The quality control laboratory is involved in a wide range of analytical techniques such as IR, Karl Fisher, HPLC, GC, AA. Other areas this job involves:
• GMP inspection of the plant area (mainly focussing on the housekeeping)
• Carrying out audits in all parts of the site – to make sure procedures are in place and these are being followed
• Representing the Quality department during external audits (e.g. FDA and MHRA)
• Creating, reviewing and updating Standard Operating Procedures (SOPs)
• Involvement in investigations following customer complaints, approving the final report
• Carrying out periodic product reviews which includes looking at quality trends (identifying step changes), making sure outstanding actions are complete, proposing areas requiring investigation/improvement
• Assessing changes on plant or in the laboratory, writing the report and recommending approval or rejection of change
• Part of the investigation team during deviations or unplanned changes, getting to root cause and proposing corrective and preventative actions (CAPA)
• Continuous improvement, as an accredited Greenbelt in the principles of Lean Sigma: Reviewing current ways of working, identifying issues, proposing change, embedding the changes/new way of working.
Other Employment History
May – Sept 97 Zeneca plc, Grangemouth
Industrial Placement in the Process Technology Department
July – Sept 96 I.F. Environment Control Services Ltd., Mauritius.
Carried out a summer project involving the evaluation of a new method for the determination of mercury level in fish using Flame Atomic Absorption Spectroscopy.
Aug 94 – July 95 Loreto Convent Quatre-Bornes (Secondary School)
Teacher (Form 1 to Form 5, aged between 11 and 15), subjects included Chemistry, Physics, Biology, Mathematics, French and English.
March 94 – July 94 Mauritius Sugar Industry Research Institute (MSIRI)
Sugar Technology Department – Laboratory Technician.
Routine analysis and new laboratory techniques in analytical chemistry.
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