+32 494 04 21 32
The Compliance Specialist is responsible for implementing policies and procedures at the Oevel site to ensure compliance with regulatory and corporate requirements. This includes:
- site owner and subject matter expert for the management of GMP documentation, change control, deviation and CAPA systems
- development of annual product review reports
- conducting internal site audits and ensuring site audit preparedness for regulatory agencies
- develop and deliver site level GMP training for new employees and re-fresher trainings as required
- develop, maintain and report appropriate quality management system metrics
- Min Bachelor’s Degree with minimum 5 years of experience in a similar role in the pharmaceutical, chemical (regulated) industry.
- You are very fluent in Dutch and English.
- Knowledge of compliance, related to all applicable Quality Systems Standards is required.
- Ability to build and deliver training modules.
- Strong and assertive oral and written communication skills to communicate information to cross functional stakeholders.
- Ability to work in a team and independently under minimal supervision.
- Proficiency in Microsoft Office Suite, Electronic QMS, e-training systems and LIMS systems is preferred.
- You are able to build and maintain relationships with people on different levels in a matrix organization.