Production Paharmacist (Hay level 16/D1) at NECSA

Position Overview:

• Reporting to the Production Managers: Radiopharmaceuticals, the incumbent will be required to ensure a routine production of all NTP’s Radiopharmaceutical products. Provide customer satisfaction with regards to product quality and reliability, i.e. time delivery while minimising production costs.

Key Performance Areas:

Product Availability and Customer Satisfaction

• Compound and dispense of FDG and possibly other Radioactive isotopes.
• Manufacture of Medical Radioactive products in accordance with cGMP requirements.
• Ensure product is dispensed to quality on time.
• Ensure efficient product packaging and verification system.
• Allocate resources and coordinate activities to meet production plan.
• Explore ways of increasing efficiencies through achieving more product with same (or less) inputs, without compromising quality.
• Continuously monitor and improve processes and systems to achieve departmental objectives.
• Manage customer complaints, nonconformities, and continual improvement by implementing the corrective actions thereof.
• Production planning and on time supply of product.
• Product adherence to customer specification.
• Effective preparation of reagents according to cGMP and ISO requirements.
• Effective component/material control to ensure availability according to ISO requirements.
• Effective utilisation or resources to keep processes cost effective.
• Maintenance of an ISO Quality Management System.
• Effective communication with support functions from orders receipt to product shipments.
• Continual staff training and effective staff management.

Quality Assurance

• Check all reagents / materials to be used are released and have approval.
• Ensure completion of all batch records and log sheets.
• Ensure all equipment in use is calibrated.
• Release final product by ensuring that all quality control tests have been completed and that all parameters are within specification.
• Approve or reject product based on compliance to specification.
• Carry out validations and compile validation reports where required.
• Stand in for Responsible Pharmacist when necessary.
• Oversee that all production is performed according to SOPs.
• Oversee processes and ensure CGMP compliance.
• Train personnel in CGMP and SOPs; and
• Continuous re-evaluation of SOPs in order to maximize efficiency of pharmacists and other staff members.

Marketing and Product Development

• Keep abreast of new developments in Radiopharmaceuticals. This involves pharmacists being actively involved in continuing education and self-study sessions.
• Perform periodic account visits and analysing trends in ordering patterns.
• Sourcing of Cyclotron/F-18 based products and services relevant to the local nuclear medicine community.
• Expansion of the Radiopharmaceutical client base and services rendered and
• Continuous evaluation of methods to maximise company profitability.

Draw on Internal Cross-Functional Resources​​​​​​​

• Use SHEQ and Regulatory inputs throughout production processes and activities.
• Embed disciplines within production functions.
• Ensure production staff always embrace safety and quality disciplines.
• View adherence to SHEQ and Regulatory as essential parts of NTP’s business model in order to serve the interests of all stakeholders.
• Liaise with the Maintenance, Technology Development and Waste departments to manage facility, equipment, processes, and waste; and
• Liaise with the Responsible Pharmacist to obtain approvals as per SOPs.

Job Requirements:

• Understanding and working knowledge of pharmaceuticals and the pharmaceutical industry.
• Knowledge and understanding of current good manufacturing practices applicable to all pharmaceuticals products.
• Full understanding of science and scientific principles.
• The ability to apply mathematical principles and laws to execute outcomes requiring mathematical application.
• The ability to communicate effectively and efficiently at all levels in the organization.
• A consistent awareness of the requirements that will ensure a safe working environment.
• Must be able to work odd hours / shifts due to the short half-life of final product.

Requirements

Qualifications and Experience:

• Bachelor of Pharmacy Degree (BPharm).
• Registered as a Pharmacist with South African Pharmacy Council.
• Preferably, five (5) years’ experience in pharmaceutical production.
• cGMP and GDocP Training will be added as an advantage.
• Exposure to cGMP regulations
• Must be medically fit to qualify as a radiation and chemical worker.

 Closing date: 22 March 2024.