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


KEY ACCOUNTABILITIES:

​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)


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


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:

Education:


Bachelor of Pharmacy Degree


Experience & Knowledge:


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


Core Competencies


Act for change
Commit to customers
Cooperate transversally
Strive for results


Skills


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


Behaviors:


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