For South Africa / Nigeria and Partner Markets Africa:
- 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, Nigeria and Partner Markets Africa
- In coordination with the Country Quality Manager, 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 Country Quality Manager
For South Africa specifically:
Product Quality and related Quality system
- Market batch release of imported finished products and locally manufactured/packaged products, including vaccines
- 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 documentation required by NCL is submitted on time
- Review of all release requirements and Perform Market Batch Release for products where Sanofi South Africa is marketing authorisation 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
- 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 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 complaints and temperature excursions
- Manage product complaints received according to Sanofi processes and standards
- Conduct trend analysis and signal detection, as appropriate.
- Product complaint reconciliation between GxP functions and relevant third parties
- Provide training on product technical complaints and maintain relevant training records.
- Provide assessments following temperature excursions to support release or use of the product
- 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
- 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 3 years of quality experience with exposure to Regulatory Affairs and Production or Distribution environment
- Act for change
- Commit to customers
- Cooperate transversally
- Strive for results
- 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
- 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 wont: 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 dont 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
Better is out there. Better medications, better outcomes, better science. But progress doesnt 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, lets 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
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
