Compliance Specialist, Randstad

Compliance Specialist

Randstad

Location:

Belgium, Braine-l'Alleud

Category:

Legal

Contract Type:

Employment contract

Salary:

Not provided

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Job Description:

We are looking for a Compliance Specialist for one of our clients based in Braine-l’Alleud. This is a contract as a Consultant (employee or freelance) until December 2025. The CPLO Compliance Specialist plays a key role in ensuring the implementation of the QMS and its related processes and governance within the CPLO organization.

Job Responsibility:

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
Work 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.

Requirements:

Excellent understanding in GMP related environment: at least 5 years of experience in the pharmaceutical industry in the field of Manufacturing or Quality
Proven and recognized expert in the field of GMP Compliance
Expert dealing 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.

Additional Information:

Job Posted:

April 12, 2025

Expiration:

May 18, 2025

Employment Type:

Fulltime

Work Type:

On-site work

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