Career for M.Pharm, M.Sc to work as Senior GMP Specialist at U.S. Pharmacopeial Convention
The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.
Post : Senior 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, US FDA’s ANDA, EDQM’s CTD, EMA’s CTD and other dossiers. The incumbent establishes manufacturing, QA, QC process, and documentation requirements for WHO prequalification, USFDA EDQM, EMA and other regulatory programs. He/she partners with the director in the evaluation of cGMP, QA, and manufacturing batch records received from manufacturers. Contributes to qualify pharmaceutical manufacturers for essential drugs supply chain management as well as for generic industry for affordable drugs worldwide.
Roles and Responsibilities:
- Designs and develops work plans and new proposals for submittal to USAID and/or other donors to obtain new funding mechanisms.
- Manages country-specific and/or regional projects for USAID cooperative agreement as assigned by US Missions in different countries.
- Develop training materials and conduct workshops on GMP compliance and product dossier evaluation.
- Prepares work plans and quarterly progress reports; contributes to annual USAID portfolio review process.
- Explores new opportunities for work in the international arena and for collaboration with other international organizations; develops and drafts proposals for international projects and activities.
- Reviews pre-audit information submitted by pharmaceutical ingredient manufacturers and makes recommendations on the readiness for a formal audit.
- Conducts site audits of drug substance and FPP manufacturing sites as the lead auditor. for a team of two.
- Creates final reports summarizing the results of the site audits and makes recommendations to the PQM GMP specialist regarding a site’s compliance with GMP.
- Reviews submitted reports and makes final recommendations to the GMP specialist regarding a site’s compliance with GMP, when contract auditors have been used.
- Prepares final disposition reports combining the audit report and document review for submissions to USAID.
- Develops and updates USP SOP's and policies related to the conducting of GMP audits for compliance.
- Provides input designed to update USP’s “Guidelines for Participants” and other documentation intended to assist current and potential participants in the program offerings.
- Participates in developing and conducting training programs for potential auditors leading to certification.
- Performs other related duties as assigned.
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