Job Location : Western Cape, Cape Town
Deadline : August 25, 2025
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Description
Fine Chemicals requires the services of a Responsible Pharmacist & QA Manager. To qualify for these positions, the most suitable candidates must fulfill the following requirements:
Requirements
Job Specifications:
- A minimum of 3-5 years of manufacturing and quality experience.
- A minimum of 5-10 years of management experience in pharmaceutical, API, or medical device manufacturing facilities.
- 3-5 years of management/supervisory experience.
- Registered with the Pharmacy Council.
- Completed internship and community service.
- Experience in validation processes and requirements.
- Internal and overseas vendor auditing experience.
- Sound knowledge of GMP regulations (European, US, UK, WHO, PICS).
- Knowledge of other pharmaceutical and scientific standards (ICH, Pharmacopoeia, etc.).
- Understanding of Quality Management Systems in pharmaceutical industries.
- Exposure to international pharmaceutical practices.
- Knowledge of engineering systems related to utilities and equipment.
- Understanding of manufacturing products and processes.
- Knowledge of packaging technology (advantageous).
- Microbiological experience (advantageous).
- Product registration experience (advantageous).
- Proficiency in MS Office and SAP.
Basic Job Functions (Brief Summary)
- Obtain permits for import/export of Schedule 5 and Substances.
- Host customer and regulatory audits.
- Complete technical, supply, and quality agreements accurately and timely.
- Ensure annual renewal with the South African Pharmacy Council (SAPC).
- Conduct periodic Management Review (QSMR) of the Quality System.
- Manage SOPs, change control, deviations, CAPA, and review of quality documents.
- Maintain compliance with standards in QSMR meetings.
- Establish policies and procedures related to scheduled substances.
- Manage release/rejection of APIs/intermediates outside FCC control.
- Ensure legal compliance with Acts such as the Pharmacy Act and Medicines Control Act.
- Perform duties as Responsible Pharmacist per Regulations 28 of the Pharmacy Act.
- Practice pharmacy responsibly per operational requirements.
- Update and implement documentation related to the Quality Unit.
- Train personnel on SOPs and relevant areas.
- Conduct internal audits.
- Participate in batch release processes ensuring GMP adherence.
- Manage Quality Management System and resources.
- Promote compliance with H&S regulations.
- Conduct supplier audits and participate in vendor management.
Personal Attributes (Brief Summary)
- Strong organizational and leadership skills, self-driven.
- Attention to detail and accuracy.
- Excellent report writing and review skills.
- High integrity and work ethic.
- Effective interpersonal, communication, training, and problem-solving skills.
- Initiative and application of advanced concepts.
- Proven leadership, motivation, and self-drive.