Posted on :
4 Nov, 2021
4 Nov, 2021
Fresenius Kabi is a global healthcare company with over 39 000 employees worldwide.
We are dedicated to a higher purpose “caring for life” which drives excellence in everything we do.
Job Title: QA Officer
Location: Port Elizabeth, Eastern Cape, South Africa
Reference #: 04112021.2
Contract Type: Permanent
Salary: Market Related
The manufacturing plant in Port Elizabeth produces both small and large volume parenterals.
The main purpose of the role is to provide support in the GMP Quality Management System elements within the Quality Assurance department. Furthermore, the successful candidate is required to work closely with departments to drive compliance to defined GMP requirements by fostering a right first quality culture.
•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.
Intermediate Microsoft office including MS Word, MS Excel, PowerPoint and Outlook
3 – 5 years’ experience in a Pharmaceutical Manufacturing Facility
•Understand Good Manufacturing Practice Regulations
•Review of validation protocols, reports
•Review of technical/engineering documentation
Application Deadline: 09/11/2021