Biologicals Operations Manager – GMP/GLP Specialist

Affirmative Portfolios; Gauteng; On-site; ZAR 871,000 - 1,178,000; Full time

Job summary

Affirmative Portfolios seeks a Manager Biologicals in Johannesburg North to oversee biologicals units and QC, ensuring GLP/GMP compliance and high-quality anti-venom production. You will lead method development, quality control and supplier management within SAVP.

The role requires a PharmD/BPharm or equivalent, registration with HA/SAPC, and extensive GMP/GLP experience in pharma manufacturing, with strong analytical and leadership skills.

Qualifications

• Four (4) year Degree/Diploma in Pharmacy (B. Pharm / BSc in Health Sciences)

Responsibilities

• To manage the activities of the biologicals units, overseeing animal units and QC department to provide high quality and cost effective anti-venom.
• To manage, investigate and implement biological industry technology within SAVP in order to ensure the efficient and effective functioning of the division, this includes conducting research and the development of new test methods and methodologies as well as of method transfers and methodologies
• To provide operational guidance and utilize technology ,laboratory, manufacturing and immunological specific knowledge in order to provide high quality and effective products to SAVP
• Provides oversight and approval of GMP (change controls, deviations, CAP,s procedures ,validation protocols) in line with SAVP,s Total Quality Management system
• To manage GLP and current GMP quality and operational systems within SAVP in order to ensure that products produced meet or exceed required specifications and internal operations are cost effective
• Designs and implements calculations spreadsheet for all tests methods and processes ensuring data integrity, also authors Standard Operating Procedures and Specifications for Stables, small animals and quality control
• To liaises with professional bodies in order to stay abreast of and in compliance with current legislation
• To manage client and supplier relationships in order to meet organisational and customer needs and to maintain the image of SAVP
• To manage, maintain and apply policies and procedures in line with GLP and GMP to ensure compliance is achieved
• Manage venom contract suppliers in terms of budget, contractual requirements deliverables, performance and quality
• Liaises with external research institutes on the technical design and efficacy of the SAVP antivenoms and assist with global research projects

Skills

Communication skills

Analytical skills

Problem solving

General management

OHSA knowledge

Computer literacy

Education

Pharmacy degree

Tools

CAD

LIS

Job description

Affirmative Portfolios seeks a Manager Biologicals in Johannesburg North to oversee biologicals units and QC, ensuring GLP/GMP compliance and high-quality anti-venom production. You will lead method development, quality control and supplier management within SAVP.

The role requires a PharmD/BPharm or equivalent, registration with HA/SAPC, and extensive GMP/GLP experience in pharma manufacturing, with strong analytical and leadership skills.