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About Candidate
I have 4 years experience in pharmaceutical QA/QC Analyst. My work experience has given me a varied skills set and the ability to work with many different types of people. It has equipped me well to benefit any team related work. I am a conscientious person who works hard and pays attention to detail. I’m flexible, quick to pick up new skills and eager to learn from others. I also have lots of ideas and enthusiasm. I always strive to be the best and I can confidently carry out post of Microbiologist or Laboratory Analyst.
Location
Education
Majored with Biochemistry and Microbiology.
Work & Experience
Validation Activities: • Understanding of Quality Management Systems (QMS) ISO 9001:2015 and ISO 13485:2016. • Understanding of validation programs aligned with SAHPRA compliance. • Understanding of validation of aseptic areas and clean rooms. Performed a series of microbial tests and documentation tasks, including: • Sterility testing through membrane filtration in a Grade-B clean room, interpretation and release of accurate results. • Background understanding of environmental monitoring on the manufacturing area, all graded areas and microbiology laboratory • Bioburden testing testing of products, water samples and tank samples to measure the microbial contamination levels before sterilization. • Particulate matter testing of intravenous solutions to determine the size and number of particles according to their size using HIAC particle counter and Binocular compound microscope. • Identification of microorganisms using Gram stain • Media and glassware preparation. • Maintaining of logbooks, filling test reports and results and archiving documents not in use or full. cGMP Activities: • Knowledge and practice of in house SOP’s and relative ISO BP 2012 & SANS/ ISO 9001: 2008 for sterility assurance of various SVP’S, LVP’S-Sterile and/or Non-Sterile products using Equinox® , with the application of aseptic technique. • Knowledge and practice of Bacterial Endotoxin testing by PYROGENT® 5000 Assay Kit (Lonza-WinKQCL) according to United States Pharmacopeia- 33 & SANS/ ISO 9001: 2008 Management Systems 7.5.1 & 7.5.2 for sterility testing assurance of various SVP’S, LVP’S- Sterile and/or Non-Sterile products
