Responsible Pharmacist

Professional Resources Partners Pty Ltd; Midrand; On-site; ZAR 500 000 - 700 000; Full time

Job summary

A leading pharmaceutical company based in Midrand, South Africa, is seeking a Regulatory Affairs and Quality Assurance Professional. The role requires a pharmacy degree, registration with the South African Pharmacy Council, and at least 2 years of experience in Quality Assurance Management, along with dossier submission expertise. The candidate will oversee regulatory submissions and ensure compliance, with a strong focus on detail and ethical work practices.

Qualifications

• Minimum 2 years Quality Assurance Management experience.
• Minimum 2 years’ experience as a Responsible Pharmacist.
• CTD dossier format submission experience.

Responsibilities

• Preparation and submission of regulatory dossiers.
• Management of local pharmacovigilance activities.
• Quality oversight of activities in manufacturing, warehousing, and distribution.

Skills

Attention to detail

Strong work ethic

Intermediate to advanced MS Word skills

Intermediate to advanced Excel skills

Intermediate to advanced PowerPoint skills

Education

Matric / Grade 12

Pharmacy degree

Registered with The South African Pharmacy Council

Job description

Summary of Position

Regulatory :

Regulatory Responsibilities

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 Responsibilities

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 : Responsible for :

• QMS & Documentation
• Conduct training on quality activities
• Audits & inspections.