Sunel Koegelenberg Email & Phone Number

Adelaide, South Australia, Australia

- Performing internal process- and study audits in accordance with GCLP, GLP and ISO17025 guidelines.- Performing external vendor qualification audits.- Evaluate audit findings, prepare and distribute reports to internal stakeholders, and review corrective action responses for acceptance and closure.- Performing QA review of incidents (deviations, quality events, complaints), assessing for criticality, impact and need for corrective and/or preventative actions and effectiveness check measures to mitigate recurrence.- Performing reviews of QA procedures.- Providing support to the project lead in quality department strategic projects.- Provide support to the lead auditor for external facing sponsor, regulatory and compliance inspections.

Australia

- Coaching staff on QMS requirements.- Assisting the Chief Quality Officer in developing, maintaining and monitoring the QMS.- Coordinating CAPAs and quality incidents.- Assisting with identifying, tracking and trending the quality metrics.- Assisting with the provision of quality reviews of clinical and study documentation including the Study Protocol, Source Documents and Investigator Site Files.- Conducting internal audits, preparing reports and following up on action items as required.-Coordinating and conducting the planning of pre-study and/or on-study site audits, external- and vendor audits to ensure that studies can be performed and data can be generated in accordance with applicable Australian and international regulatory guidelines (including ICH-GCP, TGA), relevant SOPs and the Study Protocol.- Assisting with Regulatory Oversight Inspections.- Assisting with establishing and implementing the QMS and initiatives to ensure compliance with ICH GCP requirements.

Cape Town

• Compiling Non-Conformance Reports (NCR) and Corrective- and Preventative Actions (CAPA)• Completing Risk Assessments (e.g. FMEA) and Root Cause Investigations• Compiling Change Requests• Maintaining document control as per ISO 13485 requirements• Responsible for Supplier Quality, including Supplier Qualification and Monitoring, Supplier Change Requests, Quality Assurance Agreements, Supplier Corrective Action Requests (SCAR), tracking Supplier Quality metrics for Management Review Meetings and managing Supplier Data in the ERP• Participating in the ISO 13485: 2016 Internal Audit Program as Lead Auditor• Compiling Internal Audit Reports and assigning Audit Findings• Providing support during the ISO 13485: 2016 Certification Audits• Investigating and assisting with closing Audit Findings• Writing SOPs and Work Instructions• Training staff on SOPs and Quality Principles• Developing User Acceptance Test Cases for QMS IT Tools (e.g. ETQ Reliance)

Cape Town Area, South Africa

• Managing cosmetic product notifications in accordance with Legal- and Regulatory Requirements, focused on the EU Market (EU Cosmetics Directive 76/768/EEC)• Generating Safety Data Sheets (SDS)• Participating in the ISO 22716 Internal Audit Program as Lead Auditor• Participating in the ISO 22716 Supplier Audit Program as Lead Auditor• Compiling Internal- and Supplier Audit Reports and assigning Audit Findings• Providing support during the ISO 22716 Certification Audits• Maintaining document control as per ISO 22716 and GMP requirements• Reviewing and approving packaging proofs• Maintenance of the Master Calibration Schedule, including requesting Quotes, creating Purchaser Orders and liaising with Calibration Service Providers to ensure that equipment is calibrated

Cape Town Area, South Africa

• Performing diagnostic tests on soil samples• Researching and developing fermentation trials and basic winemaking skills• Maintaining GLP• Writing SOPs, Work Instructions and creating Form Templates

Franschhoek

• HACCP Team Member• Maintaining document control as per HACCP requirements• Performing environmental testing activities (microbial swabs, tracking metrics etc.)• Completing daily quality rounds and verification checks• Performing foreign object audits• Providing induction training to staff on GMP and hygiene standards• Assisting with Non-Conformance Reports• Assisting with External- and Customer Audits

Cape Town Area, South Africa

• Manufacturing of PTCA Balloon Catheters in an ISO Class 3 Cleanroom• Daily/Weekly/Monthly cleaning of the Cleanroom facility• Performing Quality Control inspections on incoming raw materials and finished goods• Maintaining document control as per ISO 9001 requirements• Maintaining GMP throughout the facility

Bsc Hons, Genetics

Bsc, Molecular Biology And Biotechnology

Major subjects: Genetics, Microbiology, Biochemistry, Biotechnology, Botany.

Senior Certificate

Passed with distinction and honorary colours in academics.