ABOUT THE JOB:

JOB PURPOSE:

• Ensure Market Batch Release of the Sanofi South Africa Portfolio along with other local requirements related to Product Quality
• Coordinate with the Sanofi entities and Third Parties involved in the manufacturing or distribution of products for South Africa and SADC countries
• In coordination with the Country Quality Head and Product Quality and Business Support Manager: SA and SADC, ensure the implementation and continuous enhancement of appropriate Quality System covering the GxP & Health Regulated activities within the Country Organization
• Ensure business continuity in the absence of the Product Quality and Business Support Manager: SA and SADC

• 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 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

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

• 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

• Establish the annual BMR/BPR review plan
• Liaise with the concerned manufacturing sites to request the records
• Perform the BMR/BPR Review according to the schedule

• 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

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

• Bachelor of Pharmacy Degree

• Around 2 to 3 years of quality experience with exposure to Regulatory
• Affairs and Production environment

• Act for change
• Commit to customers
• Cooperate transversally
• Strive for results

• Planning and organizational 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 analyze and take action without compromising quality

• Sound understanding / knowledge of the pharmaceutical environment
• Problem solving skills
• Attentive & active listening skills,
• Able to work without supervision.
• Proactive thinking skills
• High achievement orientation with high sense of urgency.
• Ability to use sound judgment and solve problems
• Ability to work collaboratively across the business

• Push to go beyond the level we have operated until now:
  constantly challenge the status quo focusing on the priorities that will deliver the best outcomes and letting go what won't: be intolerant to mediocracy, believe we can and must do better and aim at higher but never at the expenses of our values and judgment.
• Put the interest of the organization ahead of own of those of his/her team:
  consider both short- and long-term impact of decisions; puts collective and global goals above individual or local goals; share resources and capabilities with those with the greatest need and impact; enable decision making at appropriate level.
• Act in the interest of our patients and customers:
  actively engage with customers to know their current and future needs; brings an external perspective into decisions.
• Take action and don't wait to be told what to do:
  take smart and informed best bets with the information at hand and anticipate the consequences of her/his actions; use personal judgement and others' advice to make bold and impactful decisions which move us forward.