Regulatory & Quality Control Specialist - Johannesburg, South Africa - Unique Personnel

Unique Personnel

Verified Company

Johannesburg, South Africa

2 weeks ago

Posted by:

Thabo Mthembu

beBee Recruiter

Description

Job Number

70885

Job Type

Permanent

Job Title

Regulatory & Quality Control Specialist

Computer Skills

Intermediate to Advanced MS Word, Excel, PowerPoint

Industry

Pharmaceutical

City

Johannesburg

Province

Gauteng
This person will also be the Deputy Responsible Pharmacist of the Company

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

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.
Inherent Requirements

Requirements:

Must have Matric / Grade 1
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: