Quality Assurance Officer

1 day ago

Cape Town, South Africa Clicks Group Limited Full time

**Listing reference**: click_015000**Listing status**: Online-
**Position summary**

**Industry**:Wholesale & Retail Trade
- **Job category**:Pharmaceutic**Location**:Cape Town
- **Contract**:Permanent**Remuneration**:Market related
- **EE position**:Yes**Introduction**
- We are looking to appoint a Quality Assurance Officer to work within our Unicorn division. This role will be based at our Head Office in Cape Town and report to the Compliance Manager.**Job description**

**Job Purpose**:

- To work with the current team and within their technical and specialised skills to improve and develop a competent and successful in-house quality assurance capability that will ensure and secure Unicorn Pharmaceuticals remain compliant with all regulatory and legal requirements. To take full responsibility and accountability in managing all the tasks related to Quality assurance, within the guidelines of legislation.**Job Objectives**:

- To maintain and enhance the quality management system
- To manage audits with all suppliers and distributors
- To record and manage deviations on manufacturing and distribution
- To record and trend complaints and adverse reactions
- To manage pharmacovigilance to ensure regulatory compliance
- To perform and record validations
- To compile and maintain SOPs
- To manage sampling and the final product release process
- To initiate and manage change control procedures for manufacturing and distribution
- To ensure the business remains compliant with all legal and regulatory requirements
- To manage TQA's with 3rd parties
- To manage and compile PQR's
- To perform any other duties as per changes in operational requirements of the department to deliver regulatory compliance

**Minimum requirements**

**Job related knowledge**:

- Knowledge of the generic pharmaceutical market
- Pharmaceutical industry laws, regulations and ethics (Medicines and Pharmacy Acts)
- Other industry related laws, regulations and ethics (CPA, Companies and Competitions Act)
- Understanding of Medicine Control Council Codes
- Knowledge of business processes
- Knowledge of Pharmaceutical Manufacturing, Wholesaling/Distribution
- Knowledge GWP/GDP/GMP

**Job related skills**:

- Project Management
- Planning & organising
- Policy and procedure development skills
- Legal Compliance skills
- Analytical and problem solving skills
- Communications skills, both verbal and effective writing
- People and relationship building skills
- Presentation skills

**Job experience**:

- 3 years working experience in managing quality assurance within manufacturing or distribution environment

**Education**:

- BPharm
- ISO auditing experience (desirable)

**Essential Competencies**:

- Planning and organising
- Delivering results and meeting customers expectations
- Adhering to principles and values
- Working with people
- Following instructions and procedures
- Relating and networking

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