qa validation project.

Position Summary 

Based in Gosselies, the mission of the company’s Cell and Gene Therapy is to deliver optimized process industrialization capacities to cell therapy organizations, and speed up the arrival of their therapies onto the market. From technology selection to business modeling, through GMP manufacturing, process development, quality services, the company’s teams are fully committed to helping their clients fulfill their objective of providing sustainable and affordable therapies to their patients.

To lead its increasing number of development and manufacturing projects, the company’s Cell and Gene Therapy is looking for a highly motivated QA Validation Project. 

The Role 

The QA Validation Project is responsible to implement and maintain the quality system aspects associate to his project. 

The QA Validation Project is an active member of QA Validation team. 

The QA Validation Project is responsible to implement and maintain the following quality systems. He/She : 

• Supports all Qualification & Validation include the CSV aspects in the project related matters in the company’s project.

• Ensures the review, challenge and approval, in compliance with GMP, Deviation, CAPA, Change Control, Risk Analysis, Operational documents.

• Updates and takes appropriate measures to control the risks associated with Qualification & Validation process

• Updates the Validation, Qualification and Calibration Master Plan (projects).

• Reviews and approves the Qualification and Validation protocols and rapports emitted to give the assurance they are compliance with the current regulation. Include the Validation CSV aspects for all systems and equipment with a GAMP categorisation.

• Manage and participate to the remediation activities linked with the identified gaps. 

• Write the Validation Plan and Validation Summary Report associate to the project.

• Expert in GMP environment 

• Good knowledge of quality tools ( cGMP, Well acquainted with Change control/ deviation and market compliance management system) 

• Experience of minimum 5-8 years in Quality Assurance, preferably in a biopharmaceutical company 

• Fluency in French and good speaking, reading comprehension and writing skills in English 

• Good communication skills 

• Rigorous, conscientious, flexible and honest, Quality mind, Ownership 

• Willing to bring new challenges

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 as freelance is also possible