Regulatory QA(Responsible Pharmacist) - Midrand

Minimum Requirements:

Must have Matric / Grade 12

B. Pharm degree.

Registered with the South African Pharmacy council.

At least 2-3 years regulatory experience.

Experience in compilation and submission of Act 101 (SAHPRA) Dossiers.

Thorough understanding of GMP.

Must be computer literate (MS Word, Excel and PowerPoint, intermediate to advanced skills required).

High accuracy and attention to detail skills.

Strong work ethic.

The following would enhance your position and will be an advantage:

Previous Quality Assurance Management experience.

Experience as a Responsible Pharmacist in a Manufacturing environment.

Experience in compilation and submission of Act. 36 Dossiers.

Animal Health industry experience.

Knowledge of regulatory submissions in Zimbabwe, Namibia & Zambia.

Pharmaceutical Production knowledge.

CTD submission experience will be an advantage

Main Accountabilities:

Act as Responsible Pharmacist for the entity

Regulatory Strategy & intelligence.

Responsible for the Regulatory Plan and the successful execution thereof.

Dossier preparation, compliance checks & submissions.

LOQ Answer, submission & interaction with authorities.

Maintenance & product life cycle management.

Knowledge and intelligence management.

Right level of quality & strategy.

Quality Management System& strategy.

Community building and activation.

Responsible for Pharmacovigilance.

Audits & inspections.

Product release.

CAPA identification and implementation.

Deviation and non-conformance management.

Annual Product quality review management.

Legal Compliance with Act. 101 & Act. 53