Quality Graduate at Sanofi

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

Product Technical Complaints

• 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

Temperature Excursions Management

• 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

Quality Documents Management

• 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

Country Quality Review

• Contribute to the Country Quality Review data analysis and presentation

Tracking And Filing

• Assist the Quality team in filing and tracking activities where needed

Project Management

• Assist the team on any ongoing projects and provide the relevant feedback as required

Education
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