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Responsible Pharmacist & QA Manager (Epping)

Aspen Pharma Group

Cape Town

On-site

ZAR 200,000 - 300,000

Full time

2 days ago
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Job summary

A leading pharmaceutical company in Cape Town is seeking a Responsible Pharmacist & QA Manager to ensure compliance with regulations and manage quality systems. The ideal candidate has extensive experience in pharmaceutical manufacturing and quality management, with strong leadership and communication skills. This position requires registration with the Pharmacy Council and a commitment to adherence to standards and practices.

Qualifications

  • 3-5 years of manufacturing and quality experience.
  • 5-10 years of management experience in the relevant fields.
  • Internal and overseas vendor auditing experience.

Responsibilities

  • Obtain permits for import/export of Schedule 5 and Substances.
  • Host customer and regulatory audits.
  • Ensure annual renewal with the South African Pharmacy Council.

Skills

Manufacturing experience
Quality management
Regulatory compliance knowledge
Leadership skills
Attention to detail
Interpersonal communication
Problem-solving skills

Education

Registered with the Pharmacy Council
Completion of internship and community service

Tools

MS Office
SAP

Job description

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.
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