GMP-Driven Quality Assurance Specialist

Placements24

Centurion

On-site

ZAR 500,000 - 700,000

Full time

31 hours ago
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Benefits offered by this job

Medical aid
Provident fund
Annual performance bonuses
Professional development opportunities
On-site Centurion location

Job summary

Placements24 seeks a meticulous Pharmaceutical Quality Assurance Specialist in Centurion, Gauteng. The role ensures GMP-aligned QA across manufacturing and distribution, engaging with production, QA, and regulatory affairs to sustain a strong quality culture.

You will conduct internal audits, participate in SAHPRA inspections, review batch records, CAPAs, and change controls. On-site involvement, with a focus on process improvement and regulatory compliance, drives patient safety and product

Qualifications

  • Bachelor's degree in Pharmacy, Chemistry, Biotechnology or related scientific discipline.
  • Minimum of 3 years in pharmaceutical Quality Assurance or Quality Control.
  • Strong understanding of GMP guidelines and SAHPRA relevance to pharmaceutical manufacturing.
  • Experience with internal audits and regulatory inspections.
  • Proficiency in investigating deviations, OOS results, and CAPA implementation.
  • Familiarity with validation processes (process, cleaning, analytical method validation).
  • Strong analytical and problem-solving skills with excellent attention to detail.
  • Effective communication and interpersonal skills, with the ability to collaborate across departments.
  • Proficiency in quality management software and standard office applications.
  • Knowledge of SAHPRA regulatory requirements.

Responsibilities

  • Develop, implement, and maintain Quality Assurance systems and procedures in accordance with GMP.
  • Conduct internal audits of manufacturing processes, documentation, and facilities to ensure compliance.
  • Participate in regulatory inspections from health authorities (e.g., SAHPRA) and prepare responses to audit findings.
  • Review and approve batch records, validation protocols, and other critical quality documents.
  • Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing CAPAs.
  • Manage change control processes to ensure changes to processes, materials, or equipment are evaluated and documented.
  • Perform vendor qualification audits and manage supplier quality agreements.
  • Contribute to the training of personnel on GMP principles and quality procedures.
  • Monitor key quality indicators (KQIs) and report on the status of the quality system to management.
  • Ensure proper calibration and maintenance of laboratory and manufacturing equipment.

Skills

Analytical thinking
Problem-solving
Communication skills
Interpersonal skills
Quality management software

Education

Bachelor's degree in Pharmacy
Bachelor's degree in Chemistry

Tools

QA software
Office software

Job description

Placements24 seeks a meticulous Pharmaceutical Quality Assurance Specialist in Centurion, Gauteng. The role ensures GMP-aligned QA across manufacturing and distribution, engaging with production, QA, and regulatory affairs to sustain a strong quality culture.

You will conduct internal audits, participate in SAHPRA inspections, review batch records, CAPAs, and change controls. On-site involvement, with a focus on process improvement and regulatory compliance, drives patient safety and product

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