# Sindiswa Mdushane

Sindiswa Mdushane is a remote worker on Himalayas, Laboratory Quality Review Analyst at Aspen Pharmacare, based in South Africa.

Source: https://himalayas.app/@sindiswamdushane

```text
Laboratory Quality Review Analyst at Aspen Pharmacare, reviewing GMP laboratory records and documenting investigations and CAPA follow-through.
```

| Detail | Value |
| --- | --- |
| Availability | Looking for a job |
| Location | South Africa |
| Authorized to work in | South Africa |
| Salary expectations | 30k+ ZAR |
| Job categories | Microbiologist, QA Specialist, Scientific Document Specialist |
| Skills | GMP Compliance, GCP Compliance, Laboratory documentation, Quality Control, Microbiological Testing, Sterility Testing, Bacterial Endotoxin Testing, Total Viable Count (TVC), Validation reporting, SOP Documentation, Analytical Methods, Root Cause Investigation, Impact Assessments, CAPA, Audit documentation |

## What I'm looking for

```text
I’m seeking a role in compliance, quality assurance, or scientific documentation where I can apply my GMP-focused quality oversight and experience producing and reviewing laboratory, validation, investigation, and audit documentation.
```

## About

```text
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.
```

## Experience

### Laboratory Quality Review Analyst

Aspen Pharmacare. Jan 2023 - Jan 2025

```text
Deputised for the team leader, reviewing team output and technical decisions during absences. Checked and approved laboratory documents against GMP and scientific requirements before release.
```

Skills: GMP, Document-Review, Quality-Control, CAPA, Root-Cause-Analysis, Audit-documentation, Team-Leadership

### Microbiologist - Senior

Aspen Pharmacare. Jan 2016 - Jan 2023

```text
Performed microbiological testing on raw materials, finished products, consumables and water. Wrote product validation reports, including for the COVID-19 vaccine, anaesthetics, eye drops and anticoagulants.
```

Skills: Microbiological-Testing, Report-Validation, SOP-Development, Analytical-Methods, Equipment-Qualification, Project-Leadership

### Microbiologist

[Fresenius-Kabi](https://himalayas.app/companies/fresenius-kabi). Jan 2015 - Jan 2016

```text
Trained technical staff on cleanroom gowning and behavioural requirements. Performed and reported sterility, BET and TVC testing and plate readings.
```

Skills: Cleanroom-Gowning-Protocols, Sterility-Testing, BET, TVC, Media-Fill-(Aseptic-Process-Simulation), Environmental-Monitoring

## Education

### IIE Emeris

Post Graduate Diploma, Data Analytics

```text
Pursuing a Post Graduate Diploma in Data Analytics.
```

### University of South Africa

Advanced Certificate, Total Quality Management

```text
Completed an Advanced Certificate in Total Quality Management.
```

### Nelson Mandela University

Bachelor of Science, Microbiology, Biochemistry and Physiology

```text
Bachelor of Science degree with majors in Microbiology, Biochemistry, and Physiology.
```

### Udemy

ISO 9001, ISO 14001 & ISO 45001 Internal Auditor, Quality Management

```text
Certification in ISO 9001, ISO 14001, and ISO 45001 Internal Auditor.
```

### Udemy

Advanced Certification in Clinical Research & ICH-GCP E6(R3), Clinical Research

```text
Advanced Certification in Clinical Research and ICH-GCP E6(R3).
```

### Udemy

Clinical Data Management & ICH-GCP E6(R3) Certification, Clinical Data Management

```text
Certification in Clinical Data Management and ICH-GCP E6(R3).
```

## Tech stack

- Google Docs
- Gmail
- Google Drive
- Microsoft Teams
- Google Workspace
- Trello
- Notion
- Google Sheets
- Microsoft Excel
- Zoom
- Microsoft Word
- Microsoft Outlook
- Microsoft PowerPoint

To contact Sindiswa, message them from this profile with a Himalayas employer account: [Hire on Himalayas](https://himalayas.app/hire).

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