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Senior Quality Assurance Specialist
2 months ago
About the Role:
We are seeking a highly skilled and experienced Quality Assurance Operations Specialist to join our team at ABC Worldwide. As a key member of our Quality Assurance Operations team, you will be responsible for ensuring the quality and compliance of our products and processes.
Key Responsibilities:
- Participate in projects and technical activities as a Quality Assurance Subject Matter Expert (SME) and ensure project deliverables are delivered on time and to quality standards.
- Review and approve operational documents and records, including System and Component Impact Assessments, GMP reviews, Design Qualification, IQ, OQ, PQ, functionality testing, and Cleaning Validation documents.
- Ensure compliance to quality systems is monitored and assist the QA Operations team where SME input is required.
- Drive understanding and build knowledge on expansion facilities and associated technologies to incorporate into the Company Quality sphere.
- Ensure effective management of Deviations, Change Controls, CAPAs within areas of responsibility to meet compliance requirements.
Requirements:
- Bachelor's Degree or Diploma in Microbiology / Biotechnology/Engineering/Chemical, Pharmacy or equivalent.
- At least 5 years' experience within the pharmaceutical/biotech/API manufacturing industry.
- Technical and process knowledge in controls for aseptic manufacturing, inspection, packaging, and manufacturing process principles.
- Understanding of Project management principles, Quality by design principles, and Validation & Qualification principles.
- Quality and Regulatory compliance knowledge, i.e. SA GMP, PIC/S, and WHO.
What We Offer:
We believe in the magic of diversity within teams and apply Employment Equity principles during our selection process to achieve such diversity.