Our client, a leading global medical devices company, is looking for a Clinical Quality Consultant to come on board and join their team.
You will be working with Clinical Affairs organization process owners to support all Clinical Quality CAPA activities: understanding Quality System Processes, Procedures, and tools to ensure compliance with applicable US and International standards and regulations. You will be supporting with their Quality system projects.
Key Responsibilities:
Provides maintenance support of the quality assurance tasks:
1. Support in document control activities by reviewing changes to the procedures with Business owners
2. Oversight and execution support of CAPA processes
3. Supports external audits and inspections as required, support with strategic responses, as assigned.
Provides Clinical process and procedure development support by:
4. Ensures compliance to applicable US and International Standards and Regulations by providing support for interpretation of GCP related regulations, performing gap analysis and lead activities to implement improvements.
5. Apply systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
6. Making appropriate recommendations for continuing, modifying, or abandoning proposed projects, processes and/or systems
Provides project management support, as required
Provides GCP coaching and training support.
7. Maintains relationships and communications with business and other functional areas
Requirements:
8. Ideally four to five years of Clinical or Quality functional experience.
9. Proficiency in GCP, ISO 14155:2020 requirements, EU MDR, 21 CRF 812, or ISO 13485, GMP, etc
10. This person must have excellent communication and customer service skills and strong team motivation skills in order to manage work that requires effective delivery to internal customers.
11. Detail oriented and high interest in reviewing and understanding quality system procedures
12. Hands-on approach, with the ability to dive into tasks and deliver results promptly.
Contract Information:
13. Start Date: ASAP (June 23rd).
14. Full-time.
15. 3 days/week on site in Zaventem.