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Senior Quality Assurance Specialist

2 months ago


Cape Town, Western Cape, South Africa ABC Worldwide Full time
Job Title: SME QA Operations – Quality Assurance Operations

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.