Quality Pharmacist

Our team/ Overview

The Quality team plays a critical role in ensuring that our products, services, and processes meet the highest standards of excellence, compliance, and customer satisfaction. As a cornerstone of our organization, the department is dedicated to fostering a culture of continuous improvement, maintaining regulatory compliance, and delivering quality that exceeds expectations.

The Quality department is an integral part of our operational framework, collaborating across functions to uphold and enhance the integrity of our products and processes. The team is responsible for implementing and maintaining quality management systems, performing market batch release, conducting audits, analyzing data for improvement opportunities, and ensuring adherence to regulatory and company standards.

Our Quality team is a group of passionate and skilled professionals committed to delivering results with precision and integrity. We value collaboration, innovation, and adaptability, working together to address challenges and achieve excellence. Each team member brings unique expertise, fostering a dynamic and supportive environment that encourages learning and growth.

The purpose of the Quality team is to safeguard product integrity, enhance operational efficiency, and build trust with stakeholders by ensuring that every aspect of our work aligns with established standards and best practices.

Our mission is to deliver exceptional quality in everything we do, driving customer satisfaction and trust through rigorous quality control, proactive problem-solving, and a relentless commitment to improvement. By embedding quality at the heart of our processes, we aim to support the organization's vision of delivering innovative, reliable, and compliant solutions to our customers.

Product Quality and related Quality system

• Market release of imported finished products
• Create, manage and control the market batch release forms for the whole portfolio
• Collaborate closely with Regulatory Department to ensure compliance with the product registered dossier
• Compile documents related to the Market Batch Release of every batch/shipment
• Apply for Section 36 and once off batch release request from local regulatory authority and follow-up on any request for information from their side
• Maintain an Out of specification (OOS) register and the related OOS investigation documentation
• Liaise with 3PL/Distributor for any discrepancy (quantities, product information, etc.)
• Liaise with the relevant Sanofi manufacturing Site or Contract Manufacturing Organization for topics related to Product Quality and compliance to registered dossier
• For Vaccines, ensure that the latest guidelines are followed for the release of human vaccines and timely action in creating, managing, and controlling vaccine applications on time in the local health regulatory authorities' system
• Compilation and review of all release requirements to perform market batch release for products where Sanofi South Africa is the marketing authorization holder (MAH
• Administrative batch release for products where Sanofi South Africa is not the MAH
• After the Market Batch Release of the product, manage any request to put the product on hold if required
• Regularly meet with Supply Chain to align on market batch release priorities according to stock situation
• Regularly meet with CMO and transversal internal departments to align production plan to market batch releases.
• Update the Quality Information in the Stock Cover Tracker used by Supply Chain
• Monitor and Trend batch release timelines for process improvement

• Update the sampling plan when required and communicate it to the concerned entity
• Post-Importation Testing:
  Ensure samples logistics for local and international laboratories, including South Africa NCL
• Follow-up with local and International laboratories on the post-importation testing results
• Ensure Retention Samples inventory is regularly checked for destruction, where required

• Maintain the Post-Importation Testing Exemptions…