Remote Quality Assurance Specialist

Placements24; Mtubatuba Local Municipality; Híbrido; ZAR 600.000 - 900.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Retirement savings plan

Flexible remote work schedule

Paid annual leave

Professional development support

Descripción de la vacante

Placements24 seeks a diligent Remote Quality Assurance Specialist to ensure quality and regulatory compliance for pharmaceutical products, working remotely in the Richards Bay region. The role emphasizes robust quality systems and documentation integrity.

You will implement QMS, conduct audits, review batch records and CAPAs, and support GMP-compliant manufacturing while collaborating with multiple departments. Strong communication is essential.

Formación

• Bachelor's degree in Pharmacy, Chemistry, Biology or related field.
• Minimum 4 years in Quality Assurance/Quality Control in pharma.
• In-depth GMP knowledge and familiarity with regulatory guidelines (FDA, SAHPRA).
• Experience with auditing, deviation management, CAPA and change control.
• Strong analytical, problem-solving and documentation skills.
• Excellent written and verbal communication.

Responsabilidades

• Develop, implement and maintain QMS per regulatory standards.
• Conduct internal audits of processes, documentation and facilities.
• Review and approve batch records, validation protocols and QA docs.
• Investigate deviations and CAPAs to prevent recurrence.
• Provide QA oversight for manufacturing operations under GMP.
• Train staff on quality system requirements and compliance topics.

Conocimientos

Quality Assurance

Regulatory compliance

Auditing

CAPA

GMP knowledge

Documentation

Educación

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

Descripción del empleo

About the Role

Our client is seeking a diligent and detail-oriented Remote Quality Assurance Specialist to ensure the highest standards of quality and compliance for their pharmaceutical products, working remotely within the Richards Bay region. This role is critical in upholding regulatory requirements and maintaining the integrity of our manufacturing processes and documentation. You will be responsible for implementing and maintaining robust quality systems, conducting audits, and collaborating with various departments to ensure adherence to stringent industry standards. This is a vital position for someone passionate about quality control and regulatory compliance in the pharmaceutical sector, offering a fully remote work arrangement.

Key Responsibilities

• Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with regulatory standards.
• Conduct internal audits of manufacturing processes, documentation, and facilities to identify areas for improvement and ensure compliance.
• Review and approve batch records, validation protocols, and other critical quality documentation.
• Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPAs).
• Provide quality oversight and support for manufacturing operations, ensuring adherence to GMP guidelines.
• Train personnel on quality system requirements and compliance-related topics.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• Minimum of 4 years of experience in Quality Assurance or Quality Control within the pharmaceutical industry.
• In-depth knowledge of Good Manufacturing Practices (GMP) , regulatory guidelines (e.g., FDA, SAHPRA), and quality system principles.
• Experience with auditing, deviation management, CAPA, and change control processes.
• Strong analytical and problem-solving skills, with meticulous attention to detail.
• Excellent written and verbal communication skills, with the ability to effectively document and report quality-related findings.

Benefits

• Competitive annual salary and performance-based incentives.
• Comprehensive health insurance and retirement savings plan.
• Flexible remote work schedule and the opportunity to work from home.
• Generous annual leave and paid sick leave.
• Continuous learning opportunities and professional development support.