Job Purpose:
The QA Systems Specialist is responsible of materials management including managing the suppliers’ qualification & materials quality management. In addition to the Quality shop-floor activities in Utilities (HVAC, Water stations and warehouse). Also to manage the Annual utilities review.
Responsibilities & Tasks:
1. Reviewing the compliance of Suppliers with SANOFI quality requirements:
- Supplier audit plan coordination, participation in audit & Audit reports preparation.
- Maintain an updated approved supplier list.
- Management of Mono source exit Program.
- Creation of Risk Assessments related to materials management.
- Preparation of Quality agreements with the suppliers.
- Investigation of deviations related to materials.
2. Non-Production areas shop floor activities:
- To follow GMP compliance of activities done in Warehouse.
- Participating in investigation of relevant deviations and follow up of its CAPA.
- To follow changes control system in the area of responsibility
3. HSE & Energy
- Ensures HSE approval on any SOP that requires certain HSE precautions.
- Ensures HSE approval on any change.
- Follow the laboratory safety procedures Commitment to the appropriate PPE use.
- Follow the approved HSE policy and requirements.
- Following the statutory legislation concerning Health, Safety and environmental law.
4. Respect of company values, code of ethics & social charter.
5. Perform other duties as assigned.
6. Key “MUST HAVE” competencies, skills & experiences
- QA Experience from 2-4 years
- Bachelor degree in pharmacy or science
- Successful Performance Records
- Planning & organizing skills
- Good communication & Presentation skills.
- Problem solving and organizational skills.
- Report writing skills.
- Ability to co-ordinate several inter-departmental activities.
- Good command of MS Word, Excel & Power Point.
- Good Manufacturing Practices (GMP) & Good Documentation Practices (GDP).
7. “Desirable” / compromise experience: TQM Diploma, Master in Quality
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.
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