Remote Quality Assurance Specialist
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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.
Arbeitgeber
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