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Responsible Pharmacist

4 weeks ago

Midrand, South Africa Professional Resources Partners Pty Ltd Full time

**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 labelling.
- 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
- Pharm degree
- Registered with The South African Pharmacy Council
- Minimum 2 years 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 appropriate level of quality requirements.
- QMS & Documentation
- Conduct training on quality activities
- Audits & inspections.