JOB PURPOSE
As a Graduate 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 Product Technical Complaints management.
Support the Quality Department in the management and enhancement of the assigned Quality processes related to the organization's Quality Management System.
SCOPE
South Africa, Namibia, Botswana, Eswatini and Lesotho.
Key Accountabilities
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
- Monitor the complaints mailbox, the mobile phone 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 to the South Africa PTC hub and follow up on the case progress until case closure
- Coordinate with the designated 3PL/EWD for the sample management
- Ensure the dispatch and follow up of complaint sample to the concerned investigation site
- Track complaint samples from complaint receipt until receipt by the site to ensure complaint samples are received within required timeframes
- Ensure all faulty products are followed up on according to the applicable procedure
- Perform Complaint reconciliation internally and with Third Parties where needed
- Perform regular Product Technical Complaints trending and take action where required
- In charge of delivering internal and external trainings on Product Technical Complaints handling
- Report Temperature Excursions during inbound shipments, local storage and distribution according to the Sanofi policies. This involves coordination with the concerned international distribution platforms and internal stakeholders
- Provide assessment of temperature excursions to MedInfo when needed
- 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
- Contribute to the Country Quality Review data analysis and presentation
- Assist the Quality team in filing and tracking activities where needed
- Assist the team on any ongoing projects and provide the relevant feedback as required
ABOUT YOU:
Preference for B Pharm. Science degree, BTech Pharmaceutical Sciences
Experience & Knowledge
GxP and health-related regulations
Regulatory And Company Requirements
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.
Demonstrates intercultural adaptability and sensitivity
Quick to analyze and take action without compromising quality
Behaviours
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
PLAY TO WIN BEHAVIORS
- 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, ability, gender identity or Veteran status.
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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