Supplier Quality Ivdr Documentation Specialist

2 weeks ago


Cape Town, Western Cape, South Africa Measured Ability Group Holdings Full time

South Africa - Western Cape, Cape Town - North (Goodwood - Blackheath)**
Monthly Basic Salary (Market related, Negotiable)

Our international client in the pharmaceutical industry which is based in Brackengate, Cape Town has a vacancy for a Supplier Quality IVDR Documentation Specialist.****IVDR:
- (In Vitro Diagnostic Medical Devices Regulation)**
IMPORTANT: This is a 12-month (1 Year) contract without the possibility of renewal.**
Job purpose:
You will be the primary liaison between the Supplier quality resources, Procurement, and Supplier to coordinate and manage the flow of required documentation from the supplier for IVDR submissions. You will also contribute and participate in other supplier quality-related activities as needed.

Core Accountabilities:

Coordinate, organize, and manage the IVDR documentation from suppliers required for IVDR verification.

Support in IVDR verification activities.

Support in the activities associated with the IVDR verification tool support.

Accountable for communication with suppliers, Supplier Quality, Procurement, and any other stakeholder function for the IVDR verification documentation.

Support SCARs (Supplier Corrective Action Request), as needed.

Support Supplier Onboarding Activities, as needed.

Monitoring of supplier performance and Audit preparation, as needed.

Support other supplier quality activities, as needed.

Education, experience, and skills:

Strong analytical skills (risk-based) and focus on the essential facts.

Very good written and spoken communication skills English are required, German skills are a big plus.

Excellent interpersonal skills.

Good IT skills in G-Suite and in SAP.

Locations:

You are based in Cape Town, South Africa.

General information:

Start date: 01 June 2023 _(sooner is also ok)._**
Duration: 12 months.

Extension:
Not an option.


Workplace:
Cape Town, South Africa


Workload: 100%

Home Office:
Partly possible


Department:
Supplier Quality Assurance Sub-Chapter Reagents, Ingredients, Raw Materials (DQODB).


Team: 8 Colleagues in a global setup.

Working hours:
Standard.


  • For more information please contact:
**Cobus Visser

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