Job Description

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 yearsxe2x80x99 experience as a Responsible Pharmacist
• Minimum 2 yearsxe2x80x99 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 xe2x80x93 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.

Professional Resources Partners Pty Ltd