Regulatory Affairs Pharmacist - Johannesburg

Recruiter:

Kumusa Consulting

Job Ref:

RA-01

Date posted:

Tuesday, February 22, 2022

Location:

Johannesburg, South Africa

Salary:

R 400 000 - 600 000 Per Annum

SUMMARY:
Big Pharmaceutical Company Based in Johannesburg Has An Opportunity For A RA Pharmacist.

JOB DESCRIPTION:

Prepares information needed for Quality Management System’s review meeting by trending regulatory information as per set objectives per department.
Implements identified actions and regulatory request as per senior management’s evaluation of risk.
Conducts impact assessments on new/updated formulas.
Reports monthly on regulatory updates to Quality Assurance Manager and provides progress reports when requested.
Checks all artwork to ensure regulatory requirements are met globally by using the Brand specification sheets provided.
Manages the External supplier audit schedule and ensure that audits are conducted as per the schedule.
Conducts Internal and Supplier Audits as per the relevant Audit Schedule and follows up on all non-conformances identified.
Governs the External provider approval and monitoring process.
Ensures that findings are resolved by communicating with relevant external providers.

Requirements

Bachelor of Pharmacy or BSc Degree or Diploma in Pharmacy
SAPC registration will be an advantage
Minimum 3 – 5 years’ experience in regulatory affairs
In-depth knowledge of new and emerging Acts, Regulations and guidelines pertaining pharmaceutical industry
Knowledge of FDA, EMA, WHO and local country regulations would be advantageous

NB! This job is now closed. You can apply for other jobs by uploading your CV.

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