API Manufacturing Specialist

Placements24

Soweto

On-site

ZAR 600,000 - 900,000

Full time

4 days ago
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Benefits offered by this job

Competitive salary
Medical aid & retirement fund
Paid annual & sick leave
Skill development & advancement
Safe working environment

Job summary

Placements24 in Soweto is seeking a highly skilled API Manufacturing Specialist to oversee and optimize the production of Active Pharmaceutical Ingredients. You will monitor processes, troubleshoot deviations, and ensure GMP compliance while maintaining safety and quality.

The role involves operating specialized equipment, maintaining batch records, and leading process improvement initiatives. A bachelor’s degree in a related field and at least four years of API manufacturing experience are

Qualifications

  • Bachelor's degree in Chemical Engineering, Chemistry, Pharmacy, or related field.
  • Minimum of 4 years API manufacturing or related pharmaceutical production experience.
  • Solid understanding of GMP principles and their application in API manufacturing.
  • Experience with chemical synthesis, purification techniques, and analytical methods is advantageous.

Responsibilities

  • Operate and maintain specialized equipment used in API synthesis and purification processes.
  • Monitor manufacturing processes, ensuring adherence to batch records, SOPs, and GMP guidelines.
  • Troubleshoot and resolve manufacturing deviations and process issues promptly and effectively.
  • Participate in process optimization initiatives to improve yield, efficiency, and product quality.
  • Conduct in-process testing and environmental monitoring to ensure product integrity.
  • Prepare manufacturing documentation, including batch records, deviation reports, and process change controls.
  • Train and mentor junior production operators on manufacturing techniques and safety protocols.

Skills

GMP knowledge
Problem solving
Communication & teamwork
Safety & quality

Education

Bachelor's degree in Chemical Engineering, Chemistry, Pharmacy or related field

Job description

About the Role

Our client is seeking a highly skilled and experienced API Manufacturing Specialist to join their production team in Soweto . This role is crucial for overseeing and optimizing the manufacturing processes of Active Pharmaceutical Ingredients (APIs), ensuring high-quality output that meets stringent regulatory and internal standards. You will be involved in process troubleshooting, continuous improvement, and ensuring compliance with Good Manufacturing Practices (GMP). This is an excellent opportunity for a hands‑on specialist to contribute to the production of vital pharmaceutical components within a growing facility in the Gauteng region .

Key Responsibilities
  • Operate and maintain specialized equipment used in API synthesis and purification processes.
  • Monitor manufacturing processes, ensuring adherence to batch records, SOPs, and GMP guidelines.
  • Troubleshoot and resolve manufacturing deviations and process issues promptly and effectively.
  • Participate in process optimization initiatives to improve yield, efficiency, and product quality.
  • Conduct in-process testing and environmental monitoring to ensure product integrity.
  • Prepare manufacturing documentation, including batch records, deviation reports, and process change controls.
  • Train and mentor junior production operators on manufacturing techniques and safety protocols.
Requirements
  • Bachelor's degree in Chemical Engineering, Chemistry, Pharmacy, or a related field.
  • Minimum of 4 years of experience in API manufacturing or a related pharmaceutical production role.
  • Solid understanding of GMP principles and their application in API manufacturing.
  • Experience with chemical synthesis, purification techniques, and analytical methods is advantageous.
  • Strong problem‑solving skills and the ability to work effectively under pressure.
  • Good communication and teamwork skills, with a commitment to safety and quality in Soweto .
Benefits
  • Competitive annual salary and potential for overtime pay.
  • Comprehensive medical aid and retirement fund.
  • Paid annual leave and sick leave benefits.
  • Opportunities for skill development and advancement within the manufacturing division.
  • A safe and productive working environment in Soweto .
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