RA/ QA Manager

1 week ago

Johannesburg, Gauteng, South Africa ff877176-0b14-4d67-b54b-4474a9200b66 Full time R800 000 - R1 200 000 per year

Company Description

PHARMICI (Pty) Ltd is a growing consultancy providing professional services to the pharmaceutical industry in Africa. With a wealth of experience navigating complex regulatory environments, the company helps clients ensure compliance with local and global standards to deliver safe, effective, and high-quality medicines. PHARMICI tailors its services to meet the needs of both local and multinational companies, supporting a wide range of pharmaceutical products and compliance activities. Our team specializes in regulatory affairs and other compliance areas, maintaining a strategic balance with business objectives.

Role Description

This is a temporary, on-site role for a Regulatory Affairs (RA)/ Quality Assurance (QA) Manager & Responsible Pharmacist based in the City of Johannesburg. The RA/QA Manager & Responsible Pharmacist will oversee regulatory compliance activities, manage pharmaceutical quality systems, handle product applications and submissions, monitor adherence to safety and efficacy standards, and ensure compliance with all applicable local and international regulatory requirements. The role will also involve managing documentation, providing guidance on regulatory strategies, conducting audits, and liaising with regulatory authorities.

Qualifications

  • Proven expertise in regulatory affairs and compliance within the pharmaceutical industry, including handling product registrations and submissions.
  • Strong knowledge of quality assurance principles, pharmaceutical quality systems, and compliance audits.
  • Skills in project management, organization, and the ability to meet tight regulatory deadlines.
  • Effective communication, documentation, and interpersonal skills for collaboration with internal and external stakeholders.
  • Registered pharmacist with a valid license and in good standing with relevant regulatory bodies is essential.
  • In-depth understanding of local and international pharmaceutical regulations, including Good Manufacturing Practice (GMP).
  • Experience working with pharmaceutical products across African markets is advantageous.
  • Bachelor's degree in Pharmacy or equivalent qualification is required; a postgraduate qualification in regulatory affairs or a related field is preferred.

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