Job Description

Purpose :-

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

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

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