Quality Assurance Specialist - Pharmaceutical Manufacturing

Placements24

Rustenburg

On-site

ZAR 420,000 - 620,000

Full time

6 days ago
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Benefits offered by this job

Competitive salary
Health benefits
Paid time off
Company holidays
Career advancement
Structured and safe working环境

Job summary

Placements24 is seeking a meticulous Quality Assurance Specialist to join a pharmaceutical manufacturing operation in Rustenburg. You will ensure products meet quality, safety, and efficacy standards, maintain regulatory compliance, and uphold the company's quality systems.

You will review batch records, deviation reports, and change controls, conduct internal audits, participate in external audits, and drive CAPA actions while delivering training to production personnel on GMP and SOPs.

Qualifications

  • Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
  • 3–5 years of experience in QA or QC within pharmaceutical manufacturing.
  • Strong understanding of GMP regulations and quality systems.
  • Experience with batch record review, deviation management, and CAPA.
  • Excellent analytical, problem-solving, and documentation skills.
  • Ability to work independently and collaboratively.

Responsibilities

  • Ensure adherence to GMP and other regulatory standards throughout manufacturing.
  • Review and approve batch records, deviation reports, and change control documents.
  • Conduct internal audits and participate in external audits by regulators and customers.
  • Investigate quality complaints and non-conformances; implement CAPAs.
  • Develop and maintain quality management systems and SOPs.
  • Provide training to manufacturing personnel on quality standards and procedures.

Skills

GMP knowledge
Batch record review
Deviation management
CAPA systems
Documentation
Analytical skills

Education

Bachelor's degree in Pharmacy, Chemistry, Biology, or related scientific discipline

Job description

About the Role

Our client is seeking a meticulous Quality Assurance Specialist to join their vital pharmaceutical manufacturing operations in Rustenburg. This role is critical for ensuring that all manufactured products meet the highest standards of quality, safety, and efficacy. You will play a key role in maintaining compliance with regulatory requirements and company quality systems. If you have a keen eye for detail and a commitment to excellence in pharmaceutical production, this is an excellent opportunity to contribute to a leading company in the North West province.

Key Responsibilities
  • Ensure adherence to GMP (Good Manufacturing Practices) and other relevant regulatory standards throughout the manufacturing process.
  • Review and approve batch records, deviation reports, and change control documents.
  • Conduct internal audits and participate in external audits by regulatory agencies and customers.
  • Investigate quality complaints and non-conformances, implementing corrective and preventive actions (CAPAs).
  • Develop, implement, and maintain quality management systems and standard operating procedures (SOPs).
  • Provide training to manufacturing personnel on quality standards and procedures related to production in Rustenburg.
Requirements
  • Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
  • 3-5 years of experience in a Quality Assurance or Quality Control role within the pharmaceutical industry.
  • Strong understanding of GMP regulations and quality systems.
  • Experience with batch record review, deviation management, and CAPA systems.
  • Excellent analytical, problem-solving, and documentation skills.
  • Ability to work independently and collaboratively within a team environment.
Benefits
  • Competitive annual salary and potential for bonuses.
  • Comprehensive health and wellness benefits package.
  • Paid time off and company holidays.
  • Opportunities for career advancement within a growing pharmaceutical company.
  • A structured and safe working environment focused on high-quality pharmaceutical production.
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