Responsible Pharmacist
2 weeks ago
**Summary of position**:
**Regulatory**:
Responsible for:
- preparation of good quality dossiers and submissions according to specified timelines, in designated countries, to ensure earliest registrations and approvals.
- preparation, review, and approval of product labeling.
- review and approval of product promotional materials.
- management of local pharmacovigilance activities
**Quality**:
Responsible for:
- quality oversight of activities in a defined scope (manufacturing, warehousing, and distribution.
- QC checks and release of locally manufactured products (Act 36/1947) and imported products (Act 36/1947 and Act 101/1965).
quality documentation e.g., SOPs, Annual Product Reviews, and Batch Manufacturing Documents.
- self-inspections and external audits
- assisting QA Manager in complex and external audits as required
**Requirements**:
- ** Must have Matric / Grade 12**:
- **Must have a B. Pharm degree**:
- **Registered with The South African Pharmacy Council**:
- **Minimum 2 years of Quality Assurance Management experience**:
- **Minimum 2 years experience as a Responsible Pharmacist**:
- Minimum 2 years experience in compilation and submission of Act 101 (SAHPRA)
and Act 36 (DALRRD) dossiers
- CTD dossier format submission experience
- Thorough understanding of GDP/GMP/GWP
- 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**:
- GDP/GMP/GWP Training / Certificate
- Animal Health industry experience
- Knowledge of regulatory submissions in Botswana, Namibia, Zambia and Zimbabwe
- Pharmaceutical Production knowledge.
**Main Accountabilities**:
**Regulatory**:
- Act as Deputy Responsible Pharmacist for the entity.
- Execute Regulatory Strategy
- Agency contact
- Preparation and submission of dossiers
- Maintenance & Lifecycle Management of product dossiers
- Project Management
- Regulatory due diligence on potential opportunities
- Management of local Pharmacovigilance activities
**Quality**:
- Operate at the appropriate level of quality requirements
- QMS & Documentation
- Conduct training on quality activities
- Audits & inspections.
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