SUMMARY:
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POSITION INFO:
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.
