+32 494 04 21 32
Description de l'emploi
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.