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.
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
- 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
