Group Quality Assurance Pharmacist

GROUP QUALITY ASSURANCE PHARMACIST

AI DMD: MIDRAND

Reporting to

Contract Manufacturing Manager, GQA

Job Purpose:

To review, approve and monitor all quality assurance activities at SA and international contract manufacturers ensuring compliance to cGMP requirements

Required Learning/experience

Key Job Outputs

B. Pharmacy, cGMP skills

Computer Literacy: Ms Office

3 years in Pharmaceutical manufacturing environment

2 -3 years Quality Assurance experience

Reviewing and approval of all master production and quality documentation for the Companys products.

Compiles and reviews SOPs ensuring compliance to required Guidelines.

Participates in audits conducted by GQA Auditor/s and regulatory

authorities on contract manufacturers and follow up on CAPA.

Review and approves all change controls and deviations initiated by

contract manufacturers for the Companys products.

Review and approves all investigations and CAPA initiated at contract

manufacturers relating to manufacturing, customer complaints, stability,

OOS and recalls.

Monitors validation and technical transfer batches at contract

manufacturers.

Performs QA release on the Companys products to the market.

Investigates and responds to all product/process queries timeously.

Participates in projects, product launches, product transfers ensuring

quality activities are completed timeously.

Manages the stability schedule and process for products

manufactured at contract manufacturers

Conducts quality reviews of operations at contract manufacturing sites

to identify continuous improvement actions

Implement adequate measures for all quality systems

Core Competencies

Basic QMS and Quality assurance pharmaceutical knowledge

Working knowledge and understanding of various pharmaceutical

approved guidelines

Proactive

Attention to detail

Good interpersonal skills team player

Deadline driven

Self-motivated

Problem solving

Good communication and presentation skills