QA/ RA OFFICER

A Client based in Midrand is looking for Quality Assurance  Regulatory Affairs Office

Salary Negotiable

QUALIFICATIONS:

Grade 12

RELEVANT TERTIARY EDUCATION;

B Tech / honours Degree - Microbiology / Pharmaceutical Sciences ( Advantageous)

Biochemistry, B tech Quality ( Advantageous)

Practiced /maintained ISO 90001 QMS sYSTEM

Implemented with ISO 13485

- Knowledge of granite, Evolution and Electronic QMS ( ISOMETRIX) sYSTEMS ( advantageous)

     KEY JOB FUNCTIONS;

- QMS

- Regulatory Affairs

- Auditing

- Documentation- for the QMS and Regulations

      COMPENTENCY PROFILE KNOWLEDGE;

- ISO 90001, ISO 13485 and 93/42/EEC requirements

- Quality Management System Implemantation

- Regulatory procedure / practices

-Internal and Supplier Auditing

- CE marking

- Knowledgeable in Clean rooms

Ref: JHB000122/A.M