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.

ABOUT THE JOB:

Main responsibilities

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

• Sampling Plan & Samples Management (Related to Market Batch Release activities)

• 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

• Post-Importation Testing Exemptions Dossiers (PITE)

• Maintain the Post-Importation Testing Exemptions valid
• Submit approximately three months ahead of time for renewal of any near-expiry PITE according to the applicable requirements
• Follow-up on any query by SAHPRA related to PITEs 

• Analytical Method Technology Transfer

• Support in the analytical method technology transfers from the manufacturing site to the local testing laboratory for Post-Importation testing 

• Annual Product Quality Reviews (APQR)

• Establish the yearly plan for APQR reviews
• Perform the MAH review of the planned APQRs according to the schedule
• Escalate issues raised in as per the Sanofi processes

• Batch Manufacturing and Packaging Records Review (BMR/BPR)

• Assist with establishment of the annual BMR/BPR review plan
• Assist CQM in liaising with the concerned manufacturing sites to request the records
• Perform the BMR/BPR Review according to the schedule

• Product-related quality events

• Escalate product related quality events originating from the local country office as per defined Sanofi procedures
• Co-ordinate and Support product recalls – batch trace, batch reconciliation and ensure documentation related to the recall process is complete
• Investigation of product related events and CAPA implementation

Support/ back up Country Quality Manager (Product Quality) in the following Country Quality System related activities

• Country Quality Review
• Quality Documents Management
• Deviation and Corrective-Preventive Actions (CAPA) management
• Country Quality performance indicators (QPIs)
• Country Quality agreements
• Quality risk management

ABOUT YOU:

• 2 to 3 years of quality experience
• Exposure to Regulatory Affairs and Production environment is beneficial

Education

• Bachelor of Pharmacy Degree

Soft skills

• Planning and organisational skills
• Analytical skills
• Computer skills must include working knowledge of Excel, Word and Outlook
• High level of accuracy and attention to detail, accountability for corrective actions.
• Utilizes effective interpersonal skills.
• Effective communication skills, both in written and verbal form.
• Quick to analyse and take action without comprimising quality

Technical skills

• Understanding of Regulations and Company Standards
• Proficiency in implementing, maintaining, and improving Quality Management Systems (QMS)
• Experience with documentation, deviation management, Corrective and Preventive Actions     (CAPAs), and change control processes.
• Ability to conduct internal and external audits (e.g., supplier, contract manufacturer) to assess compliance with GMP and other quality standards.
• Application of risk assessment tools (e.g., FMEA) to identify, analyze, and mitigate risks in manufacturing, distribution, and other processes.
• Understanding of production processes for pharmaceuticals, including sterile and non-sterile manufacturing.
• Knowledge of validation processes (e.g., cleaning validation, process validation, equipment qualification).
• Management of batch manufacturing records (BMRs), standard operating procedures (SOPs), and technical documentation.
• Familiarity with analytical testing methods (e.g., HPLC, GC) and laboratory procedures to interpret test results and address quality issues.
• Understanding of microbiological testing relevant to pharmaceutical products.
• Expertise in managing product complaints and executing recalls, including root cause analysis and implementing corrective measures.
• Ability to train staff on GMP, SOPs, and quality requirements.
• Proficiency in using quality software systems (e.g., QualiPSO, SAP) for QMS processes.
• Familiarity with data integrity principles and electronic records management.
• Ensuring compliance of storage, transportation, and distribution practices with GDP (Good Distribution Practice) standards.
• Monitoring cold chain management for temperature-sensitive products.
• Experience with reviewing and releasing pharmaceutical batches for distribution, ensuring compliance with all specifications and regulations.
• Knowledge of stability testing and shelf-life determination in compliance with SAHPRA requirements.

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com

Sanofi IS AN EQUAL OPPORTUNITY EMPLOYER If you are interested in applying for this vacancy and you are confident that you meet the criteria set out in the advertisement kindly click on the link below.
https://sanofi.wd3.myworkdayjobs.com/SanofiCareers
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