Noxolo Nkalitshana

Management of Quality Control, Validation and Quality Assurance Key Responsibilities: Release of incoming and finished products Control of Quality Management Systems (Audits, Customer complaints, Change Controls, QMR, etc.) Review and approval of Quality Control and Quality Assurance records Review and approval of Validation Protocols and reports Training and development of staff Planning and organising projects Preparation and monitoring of the budget

Review of qualification and validation Protocols (HVAC and Equipment) for new Lab (DQ, FQ, IQ, OQ & PQ) Compiling of User Requirement Specifications (URS) for new equipment Compiling and review of SOPs Review and release of Microbiological results Review and approve investigations of Non-Conformances Completion of Micro lab QMS (OOS, Deviations, Change Controls, Risk Assessments, CAPA’s) Staff training and Management Establishment of a new Lab; purchasing and qualifying of new equipment and consumables Quality Management Review

Complaints CAPAs Deviations Risk Assessments Root Cause Analysis Change Controls Audits (External, Internal & Vendor)

Supervise staff Training Microbiological Validations Microbiological Tests QMS Project Management

An overview of TQM and the creation and maintenance of a quality culture Developing the TQM systems and the Tools and techniques for the continuous improvement of quality Implementing TQM and sustaining continuous improvement Integrated SHEQ Management based on ISO and OHSAS system standards

Project Management Financial Management Marketing Management Operations Management Human Resource Labour Relations Marketing