Regulatory QA(Responsible Pharmacist) - Midrand - ref. r00697923

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