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 Sterile Support Specialist plays a critical role in ensuring the sterility and quality of pharmaceutical products. This position is responsible for providing support to maintain, monitor, and improve sterile processing procedures and ensure compliance with regulatory and quality standards. Development of Quality Culture in the Production Unit Strategic Development & Improvement of Quality Compliance of the Production Unit to meet international GMP standards. Training, Mentoring, and knowledge sharing of FKMSA staff to build up competences and skills in terms of pharmaceutical processes and sterile manufacturing controls, validation, in the Production, QC and QA departments. General Duties: Global Responsibilities/Duties (Global-ANNNEX-HR-000003252)

• Execution of Training activities according to plan
• Providing training courses to QC learners based on controlled and informational training content
• Assessing Learners understanding of the training content Local Responsibilities/Duties:
• Subject Matter Expert for the design of pharmaceutical processes in production, QC and QA departments with specific focus on sterile manufacturing.
• Responsible for leveraging and transferring own knowledge and expertise to the local teams in a systematic, structured, documented and auditable manner
• Responsible for the ongoing training of sterile core personnel
• Responsible for ensuring that appropriate aseptic processing control SOPxe2x80x99s, protocol and reporting mechanism are in place process / product integrity
• Responsible for remaining current and intimately abreast of all Quality Management principles and techniques, in Quality System per ICH Q10, Qualification & Validation (Process, Cleaning Validation, Computerized Systems Validation), Quality Risk Management (ICH Q9), Root-Cause-Assessment and Data Governance in order to provide relevant SME advise.
• Provides support to ensure the operational efficiency of the QA and QC department
• Conducts regular internal training of relevant Good Manufacturing Practices (GMP) and current industry practices
• Support in the preparation of the site for audits and inspections, towards international competent authorities
• Supports the GMP-compliant management of quality deficiencies, deviations, product failures, root cause analyses, and implementation of Corrective and Preventive actions, recording and trending of data.
• Responsible to perform investigations in the area of responsibility, with the support of the tool Kabitrack
• Meticulous attention to detail in documentation and sterile/aseptic processing tasks.
• Collaborative and able to work effectively with cross-functional teams and stake holders.

• Degree or National Diploma in Science, Quality, Pharmacy, Pharmaceutical Sciences
• Min. 3 yearsxe2x80x99 experience in pharmaceutical production environment in QA, QC, Validation and sterile manufacture
• Extensive experience in inspections from SAHPRA.
• Excellent knowledge of statutory requirements on the pharmaceutical industry in South Africa
• Excellent knowledge of best practices in sterile manufacturing processes and validation.