Manager Biologicals JOHANNESBURG NORTH
Medical / Emergency / Health / Lab
JHB North, Johannesburg – Gauteng
Manager Biologicals
Johannesburg North
R1 024 381pa
SIX MONTHS FIXED -TERM CONTRACT
Key Job Responsibilities:
To manage the activities of the biologicals units, overseeing animal units and QC department to provide high quality and cost-effective anti-venom in accordance with Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and Veterinary requirements
To manage, investigate and implement biological industry technology within SAVP 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 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
Managing GLP and current GMP quality and operational systems within SAVP 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 liaise with professional bodies to stay abreast of and in compliance with current legislation
To manage client and supplier relationships 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
Minimum requirements & key competencies:
Four (4) year Degree/Diploma in Pharmacy (B. Pharm / BSc in Health Sciences (Health Sciences (Healthcare Technology / Microbiology/ Immunology)
Registration with the Health Professional Council/South African Pharmacy Council as a Pharmacist
Six (6) years post qualification experience in pharmaceutical manufacturing environment (preferably in biologicals)
Knowledge of immunological process management-at least one (1) year
Knowledge of GMP and GLP
Knowledge of aseptic procedures
Knowledge of technical expertise in Quality Control testing
Validation knowledge
Knowledge of OHSA-at least one (1) year
Knowledge of general finance
Knowledge of research statistic
Knowledge of research statistics-at least I year
Computer literacy (MS Office packages, CAD & LIS)
Communication skills (verbal and written)
General Management skills
Analytical skills
Problem solving skills
Should you not hear from us within 7 days of your application, please consider as unsuccessful