Good Manufacturing Practice (GMP) Specialist - Pharmaceuticals Short Term Consultancy
Job titile: Good Manufacturing Practice (GMP) Specialist - Pharmaceuticals Short Term Consultancy (Expected vacancy). The Ministry of Health (MOH) of the Lao People’s Democratic Republic (Lao PDR), through funding secured under Round 8 grant from the Global Fund to Fight HIV/Aids, Tuberculosis and Malaria is seeking to recruit a short-term Good Manufacturing Practice (GMP) Specialist to provide technical assistance and support for the Food and Drug Department (FDD), the agency responsible for
ensuring quality assurance for the manufacture and supply of pharmaceuticals and medical commodities.
Funding has been secured to improve GMP through training including visits to local manufacturing sites.
The position is short term based in Vientiane Lao PDR. The assignment will be for two weeks over two periods and is scheduled between late June-July 2012 and October 2012, and includes per diem expenses and airfare as necessary.
The GMP Specialist will develop/review current GMP policies and Standard Operating Procedures (SOP) develop training materials and deliver short workshops to FDD staff and QA/QI staff of local manufacturing sites.
Notebook computer must be provided by Consultant.
LCD and other presentation equipment will be available.
Selection Criteria
Qualifications: Certified GMP Auditor (current) Masters degree in Manufacturing / Science related field References must be available. English language proficiency written and spoken.
Experience
• Development of training materials and workshop experience in GMP / WHO Certification
• Practical experience in auditing of pharmaceutical manufacturing sites to GMP / WHO standards.
• Development and implementation of SOPs related to GMP licensing / inspection.
• Relevant technical experience in government regulatory or scientific agencies.
• Strong practical experience with Microsoft Windows / Open Office applications.
• ASEAN and/or developing country experience.
Terms of Reference
• Review SOPs for GMP.
• Assess GMP knowledge and application.
• Develop and deliver training materials for GMP, including pre, and post evaluations.
• Liaise with other agencies in the MOH such as the national testing laboratories, and with local manufacturers.
• Conduct structured field visits to manufacturing sites.
• Deliver a report at the conclusion of consultancy to FDD with recommendations to improve licensing and inspection for GMP\
How to apply
This position is expected to be available pending finalization of Round SSF grant agreement.
Candidates must submit a cover letter and detailed CV via email or fax to the address below by 8 June , 2012. Two referees will be requested from those candidates selected for interview.
Candidates must be available for work during July 2012 & Oct 2012.
Applications by email:
Dr. Sourisak SOUNVORRAVONG
Project Coordinator GF FDD SSF
The Bureau of Food and Drug Inspection
Ministry of Health
Tel.: 856 21 254609
Fax.: 856 20 56520193
E-mail: s.sourisak@yahoo.com
Please CC Application to:
Mr. Keopouthone Procurement Unit PR Office Email keophouthone@theglobalfundlao.org
Mr. Khamlieng PHOMMAVONG Procurement Unit Email: p.khhamlieng@yahoo.com
Mr. Bounleuarn DOANGDEURNE M&E Unit Email boun_002@yahoo.com
No comments:
Post a Comment