Senior Chemistry, Manufacturing & Control Specialist - USP Ghana

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.
• Analyze customers’ feedback about training conducted 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 interlaboratory testing organized by USP-Ghana for pharmaceutical manufacturers in the region
• May represents USP at local and international conferences and meetings and provides technical guidance to donors and partners as required.

Basic Qualifications

• B.S. in chemistry, chemical engineering, pharmacy, biology, molecular biology, microbiology, or medical science
• At least five (5) years of experience in the broad pharmaceutical industry, product development, validation processes, compendial testing, regulatory affairs/pharmacovigilance 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

Preferred Qualifications

• 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. Working knowledge of French will be an advantage.
• Knowledge of medicine dossier compilation and/or working in a 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.

Supervisory Responsibilities

None

Benefits

USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing are protected.