Biologicals Ops & Quality Lead (GMP/GLP)

Isilumko Staffing; Johannesburg; In loco; ZAR 1.200.000 - 1.600.000; Tempo pieno

Descrizione del lavoro

Isilumko Staffing seeks an experienced Biologicals Manager to oversee production, quality control, and laboratory operations. The role guarantees GLP/GMP compliance and regulatory alignment while delivering cost-effective biological products.

The ideal candidate will lead R&D initiatives, manage QA/QC teams, and collaborate with regulators and external partners to drive continuous improvement across the division.

Competenze

• Four-year degree or diploma in Pharmacy or Health Sciences/related field.
• Registration with the relevant professional council as applicable.
• Minimum 6 years in pharmaceutical manufacturing, preferably biologicals.

Mansioni

• Oversee biologicals production, QA and laboratory operations.
• Ensure GLP and GMP compliance and regulatory alignment.
• Lead R&D and implementation of new testing methods and processes.
• Provide technical guidance on lab, manufacturing and immunological processes.
• Manage quality management systems including CAPAs, deviations and change controls.
• Maintain and improve quality and operational systems.
• Design testing calculations, specifications, and SOPs to support data integrity.
• Liaise with regulatory bodies and external stakeholders.
• Manage supplier relationships, budgets and contracts.
• Collaborate with external research institutions on development and efficacy studies.
• Drive continuous improvement and operational efficiency.

Conoscenze

Biologicals manufacturing

Quality assurance

GMP and GLP compliance

Immunology knowledge

Research and development

Validation and regulatory compliance

Leadership and people management

Analytical and problem-solving

Financial and budget management

Verbal and written communication

Computer literacy

Laboratory systems knowledge

Formazione

Degree in Pharmacy OR Health Sciences / related field

Professional registration with relevant council

Descrizione del lavoro

Isilumko Staffing seeks an experienced Biologicals Manager to oversee production, quality control, and laboratory operations. The role guarantees GLP/GMP compliance and regulatory alignment while delivering cost-effective biological products.

The ideal candidate will lead R&D initiatives, manage QA/QC teams, and collaborate with regulators and external partners to drive continuous improvement across the division.