QA Systems Professional (6 months contract) At Sanofi (0-2 years of experience)
Job Purpose:
-Management of GxP Training and GQD compliance follow up.
-Annual utilities review.
Job Responsibilities:
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.
5- Artwork:
-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.
6- 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 2 years ( in Sanofi or other companies )
-Bachelor degree in pharmacy or science
-successful performance records
-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).