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Senior Quality Assurance Specialist
2 months ago
We are seeking a highly skilled Senior Quality Assurance 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 pharmaceutical and biotech products.
Key Responsibilities- Participate in projects and technical activities as a Quality Assurance Subject Matter Expert (SME) to ensure project deliverables are met 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 other related documents.
- Ensure compliance to quality systems is monitored and maintained, and assist the QA Operations team as needed.
- Drive understanding and build knowledge on expansion facilities and associated technologies to incorporate into the Company Quality sphere.
- Manage deviations, change controls, and CAPAs within areas of responsibility to meet compliance requirements.
- Bachelor's Degree or Diploma in Microbiology, Biotechnology, Engineering, Chemical, Pharmacy, or equivalent.
- At least 5 years' experience in 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 and qualification principles.
- Quality and regulatory compliance knowledge, including SA GMP, PIC/S, and WHO.
We believe in the magic of diversity within teams and strive to achieve this through our employment equity principles. If you are a motivated and experienced professional looking for a new challenge, please submit your application.
