Description:
Our client is seeking a highly skilled Manager: Biologicals to oversee the activities of the Biologicals Unit, including the management of animal units and the Quality Control (QC) department. The successful candidate will ensure the production of high-quality and cost-effective anti-venom in compliance with Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and Veterinary requirements.
Key Responsibilities:
Oversee and manage the Biologicals Unit, ensuring efficient operations in line with industry standards. Supervise animal units and the QC department to maintain high-quality anti-venom production. Investigate, implement, and develop biological industry technologies to enhance efficiency. Conduct research, develop new test methods, and facilitate method transfers within SAVP. Provide operational guidance and utilize laboratory, manufacturing, and immunological expertise. Oversee and approve GMP documentation, including change controls, deviations, CAPs, procedures, and validation protocols. Ensure compliance with GLP, GMP, and cost-effective operational systems within SAVP. Develop calculation spreadsheets for test methods and processes, ensuring data integrity. Author and maintain Standard Operating Procedures (SOPs) and specifications for stables, small animals, and quality control. Stay updated with current legislation by liaising with professional bodies. Manage client and supplier relationships to meet organizational and customer needs. Oversee venom contract suppliers, ensuring budget, contractual deliverables, performance, and quality compliance. Collaborate with external research institutes on technical designs, antivenom efficacy, and global research projects.Minimum Requirements & Key Competencies:
Degree/Diploma in Pharmacy (B.Pharm) or BSc in Health Sciences (Healthcare Technology, Microbiology, or Immunology). Registered with the Health Professions Council of South Africa (HPCSA) or South African Pharmacy Council (SAPC) as a Pharmacist. 6 years of post-qualification experience in a pharmaceutical manufacturing environment (preferably in biologicals). 1 year of experience in immunological process management. Strong knowledge of GMP, GLP, aseptic procedures, and Quality Control testing. Understanding of validation processes and Occupational Health and Safety Act (OHSA) compliance. Knowledge of general finance and research statistics (at least 1 year). Proficient in MS Office, CAD & LIS. Strong communication (verbal & written), analytical, problem-solving, and general management skills.
06 Mar 2025;
from:
gumtree.co.za