Pretoria: Quality Assurance Specialist

REQUIRED NQF LEVEL Advanced Diploma or B-degree in quality management, Laboratory Science, Chemistry or Analytical Chemistry, related scientific / technical field Training or certification in ISO/IEC 17025, cGMP/PICs/WHO guidelines, Quality Management Systems or Laboratory Quality Assurance will be advantageous REQUIRED LEVEL: Operational Level, Supervisory Level, Managerial Level, Senior Managerial Level, Executive Level 8 years’ relevant experience within a GMP laboratory, quality assurance or laboratory quality management environment Operational Level Experience in pharmaceutical laboratory operations, testing processes and quality assurance systems Operational Level Specialist experience in , GMP, SAHPRA regulations, ISO/IEC 17025 Quality Management Systems and SANAS accreditatio n requirements Operational Level Exposure to laboratory equipment calibration, verification and maintenance processes, management of out of specification and out of trends and corrective actions. REQUIRED LEVEL: Entry Level, Intermediate Level, Advanced Level, Ex pert Level Relevant Legislation and regulatory frameworks (SAHPRA and SANAS) Advanced Risk Management Practices and Principles Advanced Quality Management Systems and principles Advanced Computer Literacy Intermediate Laboratory operations and testing processes Advanced Project management Advanced REQUIRED DESCRIPTION Communication Expresses and articulates key elements of ideas or concepts (both written and verbal) in a logical, descriptive, and comprehensible manner. Anticipates reactions and responds appropriately. Probes and listens for information from others, without interrupting or judging, to understand underlying issues. Planning and Organising Frequently initiates and pursues professional relationships. Works well with others in achieving goals and building productive relationships Results Orientation Personally, does what is required to complete the work. Demonstrates persistence in the face of setbacks. Consistently delivers high quality results on time. Building Relationships Initiates professional contact outside of work team, when required by job role. Maintains relationship with internal and external contacts Customer Focus Thoroughly understands the customer’s business environment, practices, and core processes. Networks with relevant decision makers at appropriate intervals. Professional and Technical Depth and Credibility Demonstrates a working, conceptual knowledge of a narrow professional, technical/specialist, or product area. Applies knowledge for basic problem solving in typical or standard situations. Makes effort to acquire further relevant knowledge. Ability to read schematic drawings. Quality Focused Follows established procedures reliably, and delivers work to defined standards of quality. Insists on thoroughness, timeliness, and accuracy of output. Teamwork Demonstrates a willingness to put team needs before those of self, and contributes to team decision making. Personal Drive Accepts responsibility for identifying new and challenging personal development needs. Constantly makes self-assessments for personal development. Is self-motivated and a self-starter. Business and Technical Mastery Demonstrates, uses, and shares a basic understanding of industry core processes and practices for developing industry-specific products/solutions / standards. Strives to acquire additional relevant industry know ledge. Problem Solving Identifies the critical elements of a problem and alternative ways of resolving it. Seeks help when necessary.