JOB PURPOSE
- As a Learner in the Country Quality Department, the purpose would be to become familiar with all aspects related to maintaining the quality management system within Sanofi South Africa with a focus on Market Batch Release and Product Technical Complaints management.
Country Quality Management System:
- Assist where needed in Developing, maintaining, and optimizing the Quality Management System in the South Africa Country organization (Quality Documents, Deviations and CAPAs, Trainings, etc.)
- Support the Quality team in addressing identified gaps. Drive the implementation of remediating action plans.
- Aim at 100% audit or inspection readiness.
- Compiling Release documentation for each inbound shipment including Certificate of Analysis, Temperature Records and Product Forms
- Coordinate with Subcontracted Distributor on release related topics
- Updating local Release Trackers to help the releasing pharmacist prioritize the releases.
- Liaise with Supply Chain teams on stock availability and expected release dates.
- Liaise with NCL lab on vaccines releases, including payments and documents submission.
- Monitor the complaints mailbox and other channels of communication.
- Identify missing information in a complaint and follow up on the receipt thereof.
- Under the supervision of the Country Quality Manager, report complaints into the database
- Track complaint samples from complaint receipt to ensure complaint samples are received within required timeframes.
- Dispatch and follow up of complaint sample to the concerned investigation site.
- Ensure all faulty products are replaced/ followed up on
- Perform Complaint reconciliation internally and with Third Parties
- In charge of delivering internal and external trainings on Product Technical Complaints handling
- Manage Temperature Excursions assessment during inbound shipments, local storage and distribution according to the Sanofi policies. This involves coordination with the concerned international distribution platforms.
- Assist in maintaining local Quality Documents aligned with global documents and local regulations.
- Where needed, assist in SOPs drafting/reviews.
- Coordinate with other GxP functions on the topics related to their Quality Documents
- Coordinating with Waltloo Manufacturing site to ensure continuous stocks of reference standards for local testing.
- Contribute to the Country Quality Review data analysis and presentation.
- Assist the Quality team in filing and tracking activities where needed.
Education:
- Preference for B Pharm. Science degree, BTech Pharmaceutical Sciences
- GxP and health-related regulations
- Regulatory and company requirements
- 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.
- Demonstrates intercultural adaptability and sensitivity
- 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 independently
- Proactive thinking skills
- Effective planning, organizing, leading and time management 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.
