On Project basis for 1 year
1- Annual GxP Training Plan management:
Creation of annual GxP training.
Follow up of training implementation on monthly basis.
2- Global Quality Documents Gap analysis
Following up the performance of gap analysis for any updated global quality documents and implementation of any raised actions from this gap analysis
Perform gap analysis for the assigned documents.
3- Non-Production areas shop floor activities.
To follow GMP compliance of activities done in Utilities (HVAC & Water stations) Participating in investigation of relevant deviations and follow up of its CAPA.
To follow changes control system in the area of responsibility
4- Annual Utilities Review:
Prepare AUR plan and follow up the plan implementation.
Collecting data from various departments concerned with AUR.
Reviewing & checking the collected data. Follow up all possible corrections if any with concerned responsible person.
Approval of artworks of different products on Vista system to ensure its compliance with the registered artwork at the
Approval of suppliers proofreading to ensure its compliance with the approved artwork.
Review and Approval of specifications for the artwork of different products on Geode+.
Investigation of any deviation related to the secondary packaging material raised from quality control or production to achieve the site KPI.
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.
Respect of company values, code of ethics & social charter.
Perform other duties as assigned.
Key “MUST HAVE” competencies, skills & experiences
QA Experience from 0 to 1 years
Bachelor degree in pharmacy or science
Good communication & Presentation skills.
Problem solving skills.
Report writing skills.
Ability to co-ordinate several inter-departmental activities.
Good command of MS Word, Excel & Power Point.
“Desirable” / compromise experience
Good Manufacturing Practices (GMP) & Good Documentation Practices (GDP).
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.