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.

• Drive and promote a continuous quality and compliance mindset within Clinical Packaging & Logistics
• Operations, ensuring compliance with cGMP’s and UCB’s Quality Management System
• Partner with Clinical Supply Compliance Team and management to lead quality initiatives that develop and maintain a high performing, scalable, and compliant quality system in CPLO. Ensure close interface with QA, CS Compliance and CPLO teams.
• Coordinate and/or participate in the implementation of new regulatory standards within CPL processes.
• Represent the interests of the CPLO teams, serve in multidisciplinary Compliance project teams, working closely with other team members in a cooperative way to ensure project progression
• Coordinate and/or conduct Quality Standards Gap analysis for the CPLO processes, risk assessment, develop remediation plan and manage tasks to completion.
• Consult and guide the teams in establishment of controls to mitigate compliance risk;
• Oversee the CPLO GMP activities and ensure all employees understand and follow all standard operating procedures.
• Works collaboratively with managers and staff throughout the CPLO organization to provide training, education and promote awareness of and help resolve regulatory and other applicable standards.
• Assist management in the coordination/management of training plans & matrix and ensure compliance with staff qualification standard.
• Participate in the development and implementation of compliance training for all CPLO staff members.
• Provide compliance mentorship and coaching to staff within the CPLO team

The requirement for this position as compliance specialist are : 

• Excellent understanding in GMP related environment : at least 5 years of experience in thepharmaceutical industry in the field of Manufacturing or Quality.
• Proven and recognized expert in the field of GMP Compliance.
• Expert dealing with with eCMS, Deviations and investigations.
• Pragmatic mindset, able to propose workable operational solutions complying to regulations
• Considers the balance between efforts, risks and benefits when resolving challenges.
• Proven ability to provide guidance for improvements and corrective and preventive actions related to quality management system processes
• Highly organized with attention to detail.
• Ability to manage multiple projects/initiatives/tasks and balance priorities.
• Ability to balance routine tasks Vs ad hoc tasks, switch execution based on specific needs or circumstances.

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.