QA Auditing - Pharma, cGMP, WHO Compliance

Company Name:
CLEAR Management Solutions
We are working on an immediate opportunity in the Rockville, MD area for a GMP Specialist. This is a hands-on, non-supervisory position where the incumbent understands the standards and principles of auditing manufacturing facilities for current good manufacturing practice (cGMP) compliance.
The incumbent will analyze all elements of a quality system and judging its degree of compliance with the criteria of quality management, evaluation and control systems. The individual leads companies in compiling dossiers for World Health Organization (WHO) prequalification's CTD and other dossiers.
This position establishes manufacturing, QA, QC process, and documentation requirements for WHO prequalification, and other regulatory programs, partners with the Director in the evaluation of cGMP, QA, and manufacturing batch records received from manufacturers and contributes to qualify pharmaceutical manufacturers for essential drugs supply chain management as well as for generic industry for affordable drugs worldwide.
Required skills and experience includes:
o CGMP drug development to commercialization
o Knowledge of developing countries for both public health sector and generic pharmaceutical market including testing and manufacturing
o Experience working for WHO prequalification program to assess dossiers and conduct GMP inspections and familiarity with WHO Common Technical Document (CTD) format for dossiers preferred. Excellent verbal, written and presentation skills; grant writing experience helpful
o An ability to network with professionals from WHO, UNICEF, UNIDO, USFDA, EDQM, EMA, GDF, Global Fund and other donor foundations as well as local in-country representatives and government officials is needed
o Ability to work with virtual teams in remote locations and with nationals from varied backgrounds and cultures. Language skills a plus (English, Spanish, French, Arabic or Mandarin)
o Minimum of seven years of work experience in the pharmaceutical industry and/or government drug regulatory authority required
o Hands-on manufacturing experience with injectable, tablet, capsule and parental pharmaceutical products is strongly preferred
o Minimum of five years' experience in at least two of the following: pharmaceutical CGMP compliance, pharmaceutical supply chain management, pharmacology, medicines evaluation. Three years of training and management experience in international programs, developing countries preferred
o Ability to travel at least 30% of the time both domestic and internationally
o An equivalent combination of education and experience may be substituted.
To explore this opportunity further please contact:
Rob Lyon
CLEAR Management Solutions
West (408) 484-6266
East (603) 888-3466
Main (866) 952-8855

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