About the company
Our client is a leading global healthcare company innovating at the intersection of health, material, and data science.
The opportunity
We are currently recruiting a qualified Compliance Specialist responsible for delivering compliance obligations for pharmaceutical products.
This job requires prior experience in managing the supply of medical products that are mainly imported from the US, and which require local authorization. The role includes certifying each production batch to ensure that it has been manufactured and controlled in compliance with the requirements of the Marketing Authorization and any other relevant regulations related to the production, control, and release of medicinal products.
Key responsibilities: Responsible for final batch certification together with the Marketing Authorisation holder. Ensure that the quality review is performed promptly and is accurate. Ensure that each batch of medicinal products has been manufactured and checked in compliance with the laws in force in that country and in accordance with the requirements of the Marketing Authorisation. Ensure the documents are evaluated, signed, stored and retrievable in accordance with the retention schedule. Rejected materials and products are quarantined. Conducts audits of Quality Management systems, processes, and procedures Managing complaints or alleged injury reporting by the customers Contact healthcare authorities about product quality-related matters Who are we looking for? Tertiary academic degree in science or related fields. 5 to 8 years of experience in quality assurance or quality management systems in the Pharma industry Detailed knowledge of Marketing Authorisation and PIC/S Guide to GMP as well as steps in manufacture Up-to-date knowledge of the regulatory requirements and quality management relevant to the products. Experience or advanced enterprise-QMS software proficiency Qualifications or knowledge in Quality Management and ISO 9001/13485 standards Who are we At PERSOLKELLY, our passion is - and always has been - putting you first. We propel our people forward by supporting their careers in fresh ways, backed by our expertise and capability. We're committed to creating a safe and inclusive environment which values and respects diverse styles, backgrounds, experience and perspectives. So it's over to you. If you would like to join our team, please APPLY now. To learn more about working with PERSOLKELLY, we encourage you to visit our website. Follow our LinkedIn page at linkedin.com/company/persolkelly for the latest updates and insights.
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