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 Technology Transfer Manager is to enhance and optimize the regulatory portfolio by strategically analyzing the files with regards to but not limited to harmonization, suppliers, batch size, specifications, test methods etc.; in cooperation with planning, production, QC, Market Unit and other stakeholders. Assume overall responsibility as SME and for Technology Transfer project coordination at the Plant.

GENERAL DUTIES:

• Subject Matter Expert for the Technology Transfer processes in production, QC and QA departments with specific focus on regulatory, sterile manufacturing and validation.
• Responsible for leveraging and transferring own knowledge and expertise to the local teams in a systematic, structured, documented and auditable manner
• To develop and maintain cooperative relationships with all regulatory bodies as well as in the maintenance of registration documents/applications/databases of all products in applicable countries.
• Ensure that local regulatory affairs unit applies latest procedures and guidelines as published.
• Contribute to the compilation of registration dossiers for submissions to authorities and relevant bodies.
• Subject Matter Expert for regulatory, validation, GMP requirements, QA and QC processes.
• Responsible for ensuring that appropriate SOPs, protocol and reporting mechanism are in place for Regulatory portfolio, Technology Transfer and related processes
• Responsible for being the single point of contact for Technology Transfer with the sales entity.
• Participating in review of any incidents / environmental excursions / anomalous events with potential for impact on process / product integrity / technology transfer.
• General Duties
• Subject Matter Expert for the Technology Transfer processes in production, QC and QA departments with specific focus on regulatory, sterile manufacturing and validation.
• Responsible for leveraging and transferring own knowledge and expertise to the local teams in a systematic, structured, documented and auditable manner
• To develop and maintain cooperative relationships with all regulatory bodies as well as in the maintenance of registration documents/applications/databases of all products in applicable countries.
• Ensure that local regulatory affairs unit applies latest procedures and guidelines as published.
• Contribute to the compilation of registration dossiers for submissions to authorities and relevant bodies.
• Subject Matter Expert for regulatory, validation, GMP requirements, QA and QC processes.
• Responsible for ensuring that appropriate SOPs, protocol and reporting mechanism are in place for Regulatory portfolio, Technology Transfer and related processes
• Responsible for being the single point of contact for Technology Transfer with the sales entity.
• Participating in review of any incidents / environmental excursions / anomalous events with potential for impact on process / product integrity / technology transfer.
• Responsible for advising and being actively involved with investment decisions at PU Port Elizabeth.
• 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.
• Management System, e.g. Deviation Management, CAPAs, Document Control, Quality Risk Management, Root Cause Analysis and Change Control
• Support in Product Quality Review process
• Responsible to perform investigations in the area of responsibility, with the support of the tool Kabitrack

• Degree or National Diploma in Science, Quality, Pharmacy, Pharmaceutical Sciences
• 5-10 years experience in Pharmaceutical production environment in QA, QC, Validation and sterile manufacture
• Extensive experience in inspections from SAHPRA
• Excellent knowledge of regulatory affairs, statutory requirements on the pharmaceutical industry in South Africa
• Excellent knowledge of best practices in technology transfer
• Extensive problem solving and product research and development knowledge

Fresenius Kabi