Job Description

Fresenius Kabi is a global healthcare company more than 40,500 employees worldwide.

We are dedicated to a higher purpose "caring for life" which drives excellence in everything we do.
The manufacturing plant in Port Elizabeth produces both small and large volume parenterals.

The main purpose of the Quality Assurance Operations Coordinator is to lead operations section to ensure GMP and QMS compliance within the company. Management of QM systems within the company.

General Duties:

• Responsible for management of all aspects of Quality management System xe2x80x93 QMS
• Handling of external audits
• Responsible for internal audits/self inspections
• CAPA management
• Administration of Risk assessments
• Complaint Management
• GMP Compliance and GMP Training (on the job) co-ordination
• Investigations/root cause analysis coordination
• Change Control management and oversight
• Review of QMS sub-systems
• QMS system improvement
• Trending of QMS data
• Mock recall handling
• Handling of Schedule 5 and 6 substances
• Rejection and administration of reject products
• Incidents and Deviations Management
• Management of QM documents
• Review and approval of QMS related documentation
• Product quality trending and review
• Co-ordination and reporting of quality key process indicators
• KabiTrack Administration and Training
• Quality Oversight in operational activities
• Responsible to conduct investigations and root cause analysis through Kabitrack.

• Possess a relevant diploma/degree in pharmacy, science, microbiology, chemistry or quality
• ISO 9001 / auditing qualification
• Sound knowledge of GMP standards as applicable to the pharmaceutical industry and sterile manufacture.
• Experience within a pharmaceutical manufacturing environment
• Experienced auditor

Fresenius Kabi