Regulatory Quality Assurance Specialist
2 months ago
Key Responsibilities:
- Act as Responsible Pharmacist for the entity, ensuring compliance with regulatory requirements.
- Develop and implement regulatory strategies to ensure successful execution of the regulatory plan.
- Prepare and submit dossiers, conduct compliance checks, and interact with authorities as necessary.
- Maintain and manage product life cycles, ensuring quality and regulatory compliance.
- Develop and implement quality management systems and strategies to ensure right level of quality.
- Build and activate community engagement initiatives.
- Oversee pharmacovigilance activities, audits, and inspections.
- Release products, identify and implement CAPA, manage deviations and non-conformances, and conduct annual product quality reviews.
- Ensure legal compliance with Act 101 and Act 53.
Requirements:
- Must have a B. Pharm degree and be registered with the South African Pharmacy Council.
- At least 2-3 years of regulatory experience, with a strong understanding of GMP and regulatory submissions.
- Intermediate to advanced computer skills, with experience in MS Word, Excel, and PowerPoint.
- High accuracy and attention to detail, with a strong work ethic.
Desirable Qualifications:
- 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, and Zambia.
- Pharmaceutical Production knowledge.
- CTD submission experience.
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