SUMMARY:
Regulatory QA(Responsible Pharmacist) - Midrand
POSITION INFO:
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
