Since August 2015
Manage clean room staff. Manage production output. Manage and Plan production clean room activities. Manage production packing activites. Manage production components and consumables.
Project Leader Calibration
November 2013 --- July 2015
Manage calibration schedule. Manage calibration staff. Plan calibration activities. Review and write calibration SOP`s. Manage expenses and budget
Senior Qualifications Technician
November 2013 --- December 2014
Project Manage and qualification of upgrade to Quality Control facility, utilities (HVAC, Purified Water, Compressed Air, Data Management System and Building Management System, Lab Gases) and lab equipment, such as incubators, fume cupboards, Sterility Isolator, Biosafety Cabinets. Responsible for ensuring calibration schedules are up to date. Draw up Validation documents in line with the local regulatory body, and in line with international guidelines.
July 2011 --- October 2013
I was responsible for the Qualification of equipment and utilities, drawing up a re-qualification program and manage the execution of those responsibilities to international standards for Process equipment, Lab Equipment, Utilities such as HVAC units with a task team. I oversaw the quality engineering aspects for utilities such as HVAC`s, Purified Water and Compressed Air. These aspects include preventative maintenance issues, breakdowns, corrective action and calibration for these utilities. Project planning including reviewing of Engineering drawings, checking that relevant SOP`s are in place. Implementing improvement actions after performing root cause analysis for the Manufacturing, Q.C Laboratory, Engineering and Packaging departments. I reviewed Manufacturing, Packaging, Q.C Laboratory and Engineering quality system and address non conformances through the suitable quality system corrective action required in line with ISO 14644, ISO 8573, ISO 3951 and ISO 9001 standards and the relevant PICS guidelines.
January 2008 --- January 2011
Project Management of a business unit completion by co-ordinating contractors and validating the work quality. Validating the design specification against the Piping and Instrument drawings. Dealing with Vendors, getting quotations, purchasing support equipment. I am responsible for the Project Validation of the piped utilities in the plant. (Purified Water, Ethanol, Nitrogen and Compressed Air) as well as qualifying Process equipment and Laboratory Instruments. Assisted with establishing and generating URS’s before items are purchased.
Various Analytical Posts
June 2000 --- June 2008
• Monitor the progression of finished products through its different stages of testing • Discuss possible improvement action for the future. • Implement improvement action • Liquid, cream, solid & cosmetic analysis • HPLC Maintenance and Calibration • Daily, weekly and monthly calibration on all lab equipment • Solvent prep for lab testing • Monthly linearity calibration to ensure accuracy in results • Wet and dry chemical analysis • Correctly identify raw material batches as per specification • Testing raw material integrity against a relevant production standard • Liaise with buyers according to quality of raw material • Identify short comings in testing methods
Innovative thinkingAnalytical thinkingCommunicativeCompetitivenessDependabilityEfficiencyProactivityProblem solvingSelf-disciplineStrategic thinkingAssertiveness
ValidationInstrument Validation ProtocolsCleaning ValidationProduct launchBiopharmaceuticals Medical devices
Skills and Expertise
ValidationManufacturingQuality assuranceQuality ControlImplement Quality Management System (QMS)Coordinate projects Create SOPs Develop protocols Report data Write protocols
Business Management Diploma in Production and Operations Management from SAIM in 2015
in Operations Management and Supervision from Nelson Mandela Metropolitan University in 2011
Certificate in Chemistry from P.E Technikon in 2003
in from St Thomas Senior Secondary High School in 1997
Training and Certification
Filter Intergrity Tester in 2013 Certification
Temperature Metrology in 2008 Certification
Mass Metrology in 2007 Certification
Chemistry in 2003 Certification