Sterile Support Specialist at Fresenius Group

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 SOP’s, 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. 

Requirements

• Degree or National Diploma in Science, Quality, Pharmacy, Pharmaceutical Sciences
• Min. 3 years’ 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.