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 Officer is to provide support in the GMP Quality Management System elements within the Quality Assurance department. To work closely with departments to drive compliance to defined GMP requirements by fostering a right first quality culture.

General Duties:

• Handling of all customer complaints/queries/adverse drug reactions and related investigations and CAPA initiation
• Event handling - review and approval in KabiTrack
• Change control review and approval in KabiTrack
• Conducting Root Cause Analysis and Risk Assessment. Includes the QA review and approval.
• GMP-related training for assigned areas of responsibility
• Initiating, coordinating, performing and following up on Internal Audits (formal and informal)
• Support during external cGMP audits by regulatory and other bodies and audit follow-up
• Support general QMS functions where required for defined areas of support and workload balance
• Review and input into Product Quality Reviews (PQR)
• Support in the administration of the electronic training management system, Netskills
• Review of GMP relevant technical/ engineering documentation
• Follow-up of all CAPAs with various departments related to Events, Audits, Self-inspections, Complaints and PQRs
• Attendance of operational and inter-departmental handover meetings in line with areas of responsibility
• Carry out other tasks within the department/ factory which are consistent with the grade, qualification and training of the incumbent.

• BSc (or equivalent) or related science (Microbiology, Chemistry, Pharmacy) tertiary qualification
• Advanced Microsoft office including MS Word, MS Excel, Powerpoint, , Lotus Notes
• 3 xe2x80x93 5 yearsxe2x80x99 experience in Pharmaceutical Manufacturing Facility
• Understanding of QMS System
• Understanding of Good Manufacturing Practice principles

Fresenius Kabi