SME QA Operations – Quality Assurance Operations

QUALIFICATIONS NEEDED:

Bachelor’s Degree or Diploma in Microbiology / Biotechnology/Engineering/Chemical, Pharmacy or equivalent.

NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE

• 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 process to manage and coordinate the implementation of changes within a manufacturing facility as a function of the Quality Management System.
• Understanding of Project management principles
• Interaction and understanding of quality role in the dynamic pharmaceutical manufacturing environment. Sound application of risk management and technical report writing.
• Understanding of Validation & Qualification principles, Quality by design principles.
• Quality and Regulatory compliance knowledge, i.e. SA GMP, PIC/S and WHO as well as application.

KEY DUTIES & RESPONSIBILITIES OF THE ROLE:

• Independently participate in projects and Technical activities as QA SME as defined by QAO Manager Participate in projects and ensure project deliverables delivered as per agreed timelines and quality. Key decision maker on quality aspects of allocated projects.
• Participate and perform independently as a key component to the wider project team.
• Where required, participate and drive with other project team members to ensure the delivery of the required key deliverables.
• Ensure quality by design, risk-based approach and risk assessments conducted and mitigated where appropriate in accordance to project timelines.
• Ensure Change management, Risk management are incorporated into all allocated projects Ensure projects integrate into the Quality management system
• Review and Approval of all operational documents and records in the projects e.g. System and Component Impact Assessments, GMP reviews, Design Qualification, IQ, OQ, PQ, functionality testing, Aseptic Process Validation, Process Validation, Analytical Method Validation, Cold-chain Packaging validation and Cleaning Validation documents, including both Protocols and Reports to ensure compliance with site approaches, cGMP and regulatory agency requirements.
• Ensure compliance to quality systems is monitored
• Assist QA Operations team where SME input is required
• Introduction and coordination of QMS principles as a key component of cGMP in the design and development of expansion facilities and the associated new technologies.
• Drive understandin...
  
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