compliance specialist 14245

In collaboration with the Clinical Supply Compliance and QA teams, the CPLO (Clinical Packaging & Logistics Operations) Compliance Specialist plays a key role in ensuring the implementation of the QMS and its related processes and governance within the CPLO organization.

There will be 2 roles in this position as compliance specialist : 

1) Transversal support : 

• Drive and promote a continuous quality and compliance mindset within Clinical Packaging & Logistics operations
• Monitoring of the quality performance
• CAPA, audit, risk management, remediation plan

2) Operational Support to the Packaging team :

• Ensure the control of packaging operations in compliance with quality standards.
• Conduct the GMP review of production Batch Records before transfer to QA
• Support in the writing of quality documents such as deviations, investigations, change controls, and SOP
• ...

The requirement for this position as compliance specialist are : 

• Minimum 5 years of experience in a similar position in QA/Compliance/Production
• Excellent knowledge of GMP
• Experience in reviewing batch records.
• A pragmatic mindset and good communication skills
• Ability to challenge QA decisions.
• Fluent in French and good knowledge of English

For this position of Compliance specialist, we offer you an attractive salary (gross monthly salary between 4000 and 4400 €) with the following benefits :

• Work life balance
  
• Group insurance
• Hospitalisation insurance  for your peace of mind
• 7 euros meal voucher per day
• Reimbursement km or company car 
• Monthly allowance (80 euros net per month)
• A 13th month
• Training to stay at the forefront of innovation

A rate as a freelancer is also possible.