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.
USP is an independent organization with nearly 200 years of experience developing quality standards for medicines.
Through its global public health programs, USP strengthens medicines quality assurance systems, increases the supply of quality-assured medicines, and develops capacity to detect and remove poor-quality medicines from the market.
By sharing scientific expertise and providing technical support and leadership, USP helps local regulators improve and sustain local health systems and enables manufacturers to supply quality-assured essential medicines for years to come.
Through these efforts, USP is able to help detect and identify poor quality health products in disease areas such as HIV/AIDS, tuberculosis, malaria and neglected tropical diseases, as well as helping safeguard the maternal, newborn, and child health sectors.
Roles and Responsibilities:
- Conducts compendial/laboratory testing of medicinal products
- Assists QMS team in the conduct of internal audits, addressing CAPAs as well as generation of audit reports
- Supports the reviews of training reports and analyze feedback for all training programs to identify trends to be used for quality improvement of training
- Assists the development of SOPs that affect training and consulting services
- Performs other tasks as assigned
- Participates in training conducted for manufacturers and students in the region in GMP, pharmaceuticals development, dossiers development etc. using approved training modes.
- Support the analysis of customers’ feedback about training conduct for industries and other stakeholders for improvement
- Supports the implementation and management of the various quality systems at USP-Ghana
- Assist in the development of technical proposals for training, testing and TA.
- Supports inter laboratory testing organized by USP-Ghana for Pharmaceuticals manufacturers in the region
- May represents USP at local and international conferences and meetings and provide technical guidance to donor and partners as required.
Required Skills or Experience
- Minimum of B.S. in chemistry, chemical engineering, pharmacy, biology, molecular biology, microbiology, or medical science
- At least five (5) years of experience of broad pharmaceutical industry, product development, validation processes, compendial testing, regulatory affairs/pharmacovilance and/or regulatory, as well as Quality Management Systems experience
- Technical knowledge of pharmaceuticals QA/QC, GMP, validation and qualification activities
- Knowledge of analytical chemistry, pharmaceutical process development, validation, quality control, quality assurance and clinical supply functions.
- Working knowledge of alternate dosage forms, which include dry powder inhalation.
- Hands on experience using traditional and advanced analytical techniques.
- Good understanding of cGxP, CMC, ICH and compendial (USP/EP/JP) regulatory requirements
- Ability to generate innovative solutions to problems and effectively work with and communicate to key stakeholders.
- Understanding of ICH Guidelines documents including; Safety Guidelines, Quality Guidelines, Efficacy Guidelines, and Multidisciplinary Guidelines
- High level of integrity and commitment to quality.
- Strong commitment to personal and team accountability.
- Ability and desire to work well with diverse employees and customers in a cooperative and friendly manner.
- Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
- Capacity to handle multiple priorities and balance work to achieve business goals.
- Good communication and presentation skills, both verbal and written. A working knowledge of French will be an advantage.
- Knowledge of medicine dossier compilation and/or working in GMP environment.
- Understanding of regulatory standards such as ISO 9001, ISO 17025 and/or WHO GPCL prequalification requirement
- Results driven with demonstrated successful outcomes
How To Apply
All interested applicants should send their CVs to GHProcurement@USP.org not later than January 15, 2022.
Closing Date: January 15, 2022.