Description
Upcoming activities:- Assisting project teams to ensure that the site procedures are followed in� projects
- Monitoring of project quality and schedule of deliverables
- To support project teams in preparing and writing validation documents.
Given the complexity of the quality aspects in an aseptic site, experience in one or more of the following areas is important:
- Experience (s):
o the pharmaceutical sector
o an aseptic site
o sterilisation, cleaning, aseptic handling, vial filling, inspection and secondary packaging processes
o Reviewing and writing test protocols / reports
o testing and documentation for testing machines
o perform startup and / or construction and / or programming of machines
o Project work
- Knowledge of:
o IMPs,
o Validation, Qualification, C & Q, verification (ASTM)
o Risk management tools: FMEA, HAZOP, Cause & effect analyzes
Knowledge in the following domains required:
o GAMP5
o CFR21Part11
o PLC (Siemens)
o Historian (Plant Information OSI Soft)
o Production System (Oracle)
Desired education & experience:
o Engineer or equivalent experience
o Experience in the Pharma is required.
o Experience and knowledge of processes for creating sterile medication in aseptic environment.
Required skills:
o Team player
o Analytical
o Independent
o Good communication skills