Country Quality Learner at Sanofi

JOB PURPOSE:

• As a trainee in the quality department, the purpose would be to become familiar with all aspects related to managing quality documentation and maintaining the quality management system within sanofi. The aim of fulfilling the role of a Quality Managment System officer. In addition assist quality pharmacist in all related product quality activities.

KEY ACCOUNTABILITIES

Country Quality Management Systems

• Assist in Developing, maintaining and optimizing a quality system in the South Africa Country organization

Product complaints

• Monitor the complaints mailbox
• Identify missing information in a complaint and follow up on the receipt thereof
• Under the supervision of the quality pharmacist report complaints into the database
• Tracking of complaint sample from complaint receipt to ensure complaint samples are received within required timeframe
• Ensure all complainants faulty product is replaced/ followed up on
• Dispatch and follow up of complaint sample to investigation site
• Complaint reconciliation with third parties

Product Quality Reviews

• Contact third parties managed by the local country organisation
• Track PQR review and sign off

Compilation and reporting of distribution KPI’s

• Monthly compilation of KPI’s per BU

Maintenance of quality databases
Supply chain tracker

• Quality Agreements, ensuring appendices are maintained and up to date and tracked appropriately
• Complaints samples tracker
• Maintenance of Quality Sharepoints

Support of market release of product

• Sample management
   
  • Liaise with local and international laboratory on incoming samples for testing
  • Match the incomming product sample with the relevant CoA, packing list and invoice
  • Inspect the samples attributes prior to handover to a Pharmacist
  • Download temperature data & action as appropriate
  • Sample dispatch to testing laboratory and track to receipt

Change Control management:

• Tracking and management of change control from third party contract manufacturing organisations

Database management:

• Ensuring all tracking databases are up to date and maintained

Maintenance of Quality Sharepoints Documentation management control:

• Management of master documents
• Change required to master document:
   
  • initiate a change control
  • ensure change control is signed off by all required stakeholders
• maintain local quality sharepoint and achieveing of all quality docuemnts
   

Screening for released global quality documents

• receive monthly quality document update.
• summarise proposed changes in consultation with Pharmacist/ CQH
• Track notification of the process owner and implementation of action plans

Documentation management control:

• Management of Country Quality documents (creation and control of master documents )
• Maintenance of specification books between county organization and manufacturing sites.
• Standard operating procedure & work instruction mapping, achieving and maintenance for all GxP function

JOB-HOLDER ENTRY REQUIREMENTS :
Education:

• Science degree, BTech Pharmaceutical Sciences/ Pharmacist would be an advantage
   

Experience & Knowledge:

• 1 year quality (preferred) / 1 year pharma industry experience
• GxP and health-related regulations
• Regulatory and company requirements
   

Core Competencies

• Act for change
• Commit to customers
• Cooperate transversally
• Strive for results
   

Skills

• 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
   

Behaviours:

• Sound understanding / knowledge of the Pharmaceutical environment
• Problem solving skills
• Attentive & active listening skills,
• Able to work without supervision.
• 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
   

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.