(3-year contract position (renewable), based in Capital Park, Pretoria)Please quote the vacancy reference number QAM01 in all communicationsClosing date: 21 June 2024About the employer: The Nuclear Medicine Research Infrastructure (NuMeRI) is part of the Department ofScience and Innovation's (DSI) South African Research Infrastructure Roadmap (SARIR) established in2015. NuMeRI is registered as a non-profit company, providing a framework to consolidate expertise and toimplement new strategic initiatives in nuclear technologies in medicine and the biosciences, creatingsignificant Research, Development and Innovation (RD&I) capacity in South Africa. The Nuclear MedicineResearch Infrastructure provides enabling support for health care research and development by SouthAfrican researchers. NuMeRI is dedicated to transforming the field of nuclear medicine by facilitatinggroundbreaking research, promoting collaboration, and driving innovation to improve patient care, informimproved teaching and learning practices and outcomes.NuMeRI is a network of medical imaging and theragnostic facilities dedicated to drug development andclinical research, is a not-for-profit company, providing a framework to consolidate expertise and toimplement new strategic initiatives in nuclear technologies in medicine and the biosciences, creatingsignificant Research, Development, and Innovation (RD&I) capacity in South AfricaThe research infrastructure will provide enabling support for healthcare research, development, andinnovation for academia as well as commercially driven healthcare companies (pharmaceutical andbiotechnology).Job purpose:The Quality Assurance Manager will help to ensure the consistent production of safe, effective, and high-quality radiopharmaceutical products that meet regulatory requirements and industry standards at the sitelevel. This involves overseeing all aspects of quality assurance throughout the manufacturing process inalignment with company objectives, including testing, documentation, and compliance with GoodManufacturing Practices (GMP) and other applicable regulations. Additionally, the Manager is responsiblefor implementing quality improvement initiatives, training staff, and facilitating communication betweendifferent departments to maintain and enhance the overall quality management system.Essential Functions:• Communicates aligned quality objectives and requirements to company management and co-workerswith a goal to foster a company-wide culture of quality focus and compliance.• Implement, manages and executes a quality management program consistent with pharmaceuticalmanufacturing requirements for API starting material and finished drug products.• Executes and enhances quality aspects of project-specific plans to support company goals.• Participates in company initiatives to apply quality principles to procedures and standards.• Reviews design specifications, procedures, and other technical documents to ensure GXP alignmentwith GXP requirements.• Oversees and execute Change Control for TPI processes subject to quality requirements.• Develop personnel training related to quality and good manufacturing practices.• Oversees and executes implementation and training of the Quality Management System (QMS).• Oversees and/or execute batch record approval process and acts as responsible manager ensuringquality attributes of batch.• Manages the audit program, including regular internal audits and a supplier audit program. Directsthe resolution of findings and ensures proper follow-up.• Signatory to Technical Quality Agreements associated with GMP Agreements.• Manages and execute Corrective and Preventive Action (CAPA) program, Continuous Improvementinitiatives, Risk Management, and Out-of-Specification (OOS) Investigations.Qualifications:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Therequirements listed below are representative of the knowledge, skill, and/or ability required.• Bachelor's Degree in a science, health, or related field (extensive equivalent QA experience in apharmaceutical discipline may be considered as a substitute for academic degree and will be apreferred advantage).• At least 5-7 years of progressive experience in GMP, QA management or QA pharmacist in thePharmaceutical Manufacturing Industry and/or Medical Device Industry is required.• Experience with manufacturing of sterile products, with aseptic bioprocessing expertise preferred.• In-depth knowledge of radiopharmaceutical manufacturing processes is preferred, with a proven trackrecord of implementing and maintaining robust quality management systems.• Experience in compliance with Current Good Manufacturing Practices (cGMP) for pharmaceuticalsand South African Health Products Regulatory Authority (SAHPRA) is required, and experience withGood Clinical Practices, and Good Laboratory Practices is preferred.• Must have experience with quality risk management, corrective and preventative action (CAPA), RootCause Analysis, Continuous Improvement, and OOS investigations.Knowledge / Skill / Ability:• Understand the principles of radiation safety and apply worker safety considerations to procedures,with the guidance of Perspective radiation safety experts.• Understanding of sterile pharmaceutical manufacturing requirements.• Must have keen attention to detail with the ability to read and interpret regulatory requirements andindustry standards and apply information to quality standards.• Excellent written, verbal, and interpersonal communication skills, with proven ability to collaborate,communicate and manage well at all levels of the organization.• Must be proficient in Microsoft suite and able to master application of different software.• Demonstrated ability to work independently, manage projects and lead change across theorganization.• Ability to focus on critical issues and balance and respond to competing short-term and long-termpriorities.• Commitment to continuous improvement to drive excellence in aseptic, radiopharmaceutical qualityassurance practices.• Ability to facilitate meetings and discussions in person and virtually.• Ability to travel/work out of official working hours.• Must be fluent in English (read, write, speak) as a medium of business instruction at NuMeRI.Life-long learner – willingness to learn new concepts in relation to quality management in theRadiopharmaceutical Industry.Work Environment:The work environment characteristics described here are representative of those anemployee encounters while performing the essential functions of this job.• Must be willing to work in a facility producing radioactive materials and requiring allemployees to participate in safety programs designed to minimize potential and/or actualexposure levels.• Must be able to work outside of regular work hours, including off shift, weekend, andholiday work as business needs require.• May be required to sit or stand for long periods of 8+ hours a day while performing duties.• Occasional kneeling, crouching, twisting the upper body, bending, stooping, pushing,pulling, or reaching may be required.• Must possess good hand-eye coordination; close attention to detail is required.• Must be able to work indoors and outdoors with exposure to mechanical/moving parts,hazards including radioactive, corrosive, flammable and toxic material. dust, dirt, odors,and irritants.• Must be willing to wear a variety of Personal Protective Equipment (PPE), including eyeand hearing protection, as needed.• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.Please note this job description is not designed to cover or contain a comprehensivelisting of activities, duties or responsibilities that are required of the employee for thisjob. Duties, responsibilities, and activities may change at any time with or without notice.For this three-year contract (renewable) position, the MRC offers a total cost-to-companyremuneration package will be negotiated in accordance with qualifications and experience.Interested candidates should send their CV, a cover letter of motivation and contact details ofthree referees to: Ms Ntombi Ditlopo, Email: ****** quote the reference number in the subject line of your email, CV and all othercommunications. Certified copies of your ID and highest formal qualifications must be submittedwith this application. The NuMeRI team retains the right not to make an appointment and subscribes to the principles of Employment Equity.#J-18808-Ljbffr
