Summary of the Position
The Senior Chemistry, Manufacturing and Control (CMC) Specialist is a professional position within GHMS. The incumbent resides in Ghana, and s/he will support the development of training materials and conduct of training in Good Manufacturing Practices (GMP) for both National Regulatory Authorities (NRAs) and medicines/pharmaceuticals manufacturers. S/he will conduct laboratory testing and supports validation activities and technical assistance (TA) programs at USP Ghana and will travel across the African region for official assignments when needed.
Roles and Responsibilities
- Conducts compendial/laboratory testing of medicinal products
- Assists quality management system team in the conduct of internal audits, addressing corrective and preventive actions 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
- Partners in the development of standard operating procedures that affect training and consulting services
- Performs other technical functions as may be required such as supporting the implementation of PQM+ program.
- Participates in training conducted for manufacturers and students in the region in GMP, pharmaceuticals development, dossiers development etc. using approved training modes.
- Analyzes 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
- Partners 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.
- 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
- Demonstrated technical knowledge of pharmaceuticals quality assurance and quality control (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, international conference on harmonization (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 Good Practices for Pharmaceutical Quality Control Lab (GPPQCL) prequalification requirement.
- Results driven with demonstrated successful outcomes.
USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing are protected.
The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world’s top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP brings together more than 1,100 talented professionals across five global locations to deliver its mission to strengthen the supply of safe quality medicines and supplements worldwide. USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities. USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.
Job Category Chemistry & Scientific Standards
Job Type Full-Time