All meaningful care comes down to people with the experience, expertise, and compassion to make a difference in the lives of those facing challenging situations. For us, care is a fundamental obligation, mission, and daily source of inspiration. It is the momentum that pushes us forward to help elevate the quality of life for both caregivers and those who ne...
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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 SOP’s, 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 SOP’s, 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
Requirements
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
Gmail
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