Sindiswa Mdushane

At Aspen Pharmacare, I reviewed laboratory documents against GMP and scientific requirements before release, and controlled document versions and traceable records for audit preparation.

As a Laboratory Quality Review Analyst, I deputised for the team leader by reviewing team output and technical decisions during absences. I also coordinated audit questions and drafted written responses.

Previously, as a Senior Microbiologist at Aspen Pharmacare - Gqeberha, I performed microbiological testing and wrote product validation reports, including for the COVID-19 vaccine. I authored and revised SOPs, analytical methods and work instructions, and led a multidisciplinary review of post-intervention sampling.

At Fresenius-Kabi - Gqeberha, I performed and reported sterility, BET and TVC testing, trained technical staff on cleanroom requirements, and supported aseptic process simulation and validation reporting. My background includes more than 10 years in regulated pharmaceutical environments, with GMP-focused quality oversight and scientific documentation.