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:
- Support in document control activities by reviewing changes to the procedures with Business owners
- Oversight and execution support of CAPA processes
- Supports external audits and inspections as required, support with strategic responses, as assigned.
Provides Clinical process and procedure development support by:
- 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.
- Apply systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- 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.
- Maintains relationships and communications with business and other functional areas
Requirements:
- Ideally four to five years of Clinical or Quality functional experience.
- Proficiency in GCP, ISO 14155:2020 requirements, EU MDR, 21 CRF 812, or ISO 13485, GMP, etc
- 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.
- Detail oriented and high interest in reviewing and understanding quality system procedures
- Hands-on approach, with the ability to dive into tasks and deliver results promptly.
Contract Information:
- Start Date: ASAP (June 23rd).
- Full-time.
- 3 days/week on site in Zaventem.
