Quality Assurance Specialist - Pharmaceuticals

Placements24; United States; Hybrid; USD 26,000 - 37,000; Full time

Benefits offered by this job

Health insurance

Retirement contributions

Professional development

Hybrid work model

Job summary

Placements24 is seeking a detail-oriented Quality Assurance Specialist to join its team in Welkom, SA. This hybrid role focuses on maintaining quality, safety, and efficacy of pharmaceutical products through QMS development, audits, and deviation investigations.

You will review batch records, ensure GMP compliance, and drive CAPA actions while collaborating with cross-functional teams to uphold patient safety and product quality in a dynamic manufacturing environment.

Qualifications

• Bachelor's degree or higher in a scientific field related to pharmaceuticals.
• Minimum 2–3 years in QA or QC within pharma.
• Solid knowledge of GMP and regulatory guidelines (e.g., SAHPRA).
• Experience auditing, reviewing documents, and investigating deviations.

Responsibilities

• Develop, implement, and maintain the Quality Management System (QMS).
• Conduct internal and external audits of suppliers and processes.
• Investigate quality complaints and deviations; implement CAPAs.
• Review batch records, validation protocols, and change controls.
• Monitor quality metrics and report to management on KPIs.
• Ensure compliance with GMP and related regulatory standards.

Skills

Attention to detail

Analytical skills

Problem-solving

Auditing

CAPA

Education

Bachelor's degree in Pharmacy, Chemistry, Biology or related field

Tools

QMS software

Job description

About the Role

Our client is looking for a detail-oriented Quality Assurance Specialist to join their team in Welkom . This hybrid role is essential for ensuring that all pharmaceutical products manufactured and distributed meet the highest standards of quality, safety, and efficacy. You will be involved in developing, implementing, and maintaining the quality management system, conducting audits, and investigating deviations. The position requires a strong understanding of regulatory requirements and a commitment to upholding quality principles, offering a valuable opportunity to contribute to patient safety within the Free State province while benefiting from a flexible hybrid work arrangement.

Key Responsibilities

• Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with regulatory standards.
• Conduct internal and external audits of suppliers, contract manufacturers, and internal processes to ensure compliance.
• Investigate product quality complaints and non-conformances, identifying root causes and implementing corrective and preventive actions (CAPAs).
• Review and approve quality-related documentation, including batch records, validation protocols, and change controls.
• Monitor and analyze quality metrics, providing regular reports to management on key performance indicators.
• Ensure compliance with all relevant pharmaceutical regulations, including Good Manufacturing Practices (GMP).

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• Minimum of 2-3 years of experience in a Quality Assurance or Quality Control role within the pharmaceutical industry.
• Strong knowledge of GMP, regulatory guidelines (e.g., SAHPRA), and quality systems.
• Excellent attention to detail, analytical skills, and problem-solving abilities.
• Experience with auditing, documentation review, and deviation investigations.
• Ability to work effectively both independently and as part of a hybrid team.

Benefits

• Competitive salary and annual bonus potential.
• Comprehensive health insurance and retirement fund contributions.
• Opportunities for professional development and further training in quality assurance.
• Hybrid work model providing flexibility and work-life balance.
• A collaborative environment focused on maintaining the highest quality standards in pharmaceutical manufacturing.