qa sterility assurance -medior - 94866.

Requirements :

• quality and compliance mindset 
• problem solving
• understand quickly
• French/english

Purpose of the job :

Provides support and expertise to the operations to ensure that the Manufacturing Performance Unit applies all Sterility Assurance processes (including Aseptic Practices, Environmental Monitoring, Cleaning and Sanitization, Sterilization, Media Simulation, change over, sterile hold time, container closure integrity, sterile filtration,…) to confidently deliver products to patients with the highest sterility assurance level at an appropriate cost.

Support team to:

• Projects related to Sterility Assurance
• Approval of scientific and technical reports (test procedure, validation report, risk assessment, scientific report, …)
• The re-qualification activities after shut down (PQ EM, among others)
• Write procedures in relation with sterility assurance
• Perform FMEA analysis on aseptic processes
• Ensure the adequate treatment of all deviation linked with sterility assurance
• Ensure and support the implementation of adequate training for aseptic gowning and practices (isolator and conventional processes) and sterility assurance, including shop floor mentoring as required
• Ensure compliance to local and international standards, cCMPs, Regulatory requirements and all company Quality Management Systems (QMS) policies and procedures as applicable as well as adherence to the Environmental, Health and Safety rules

Consultancy

We offer an attractive salary with extra-legal advantages: 

• Group insurance
• Hospitalisation insurance
• Meal vouchers of 7 euros gross per working day
• Reimbursement km or company car 
• Monthly allowance (80 euros net per month)
• A 13th month
• Training
• Etc.

A rate is freelance is also possible