Description
QA Specialist - 24 Months initially - BelgiumJob Summary
To support Quality Management System activities, manage quality processes, create and update compliances.
The QA specialist will work independently with minimal supervision and have basic knowledge of supply chain processes and distribution.
Principal Duties and Responsibilities
- Responsible for CAPAs, Documentation control, trainings, internal and external audits, management reviews, corporate KPIs, corporate integration process (adopting of new procedures)
- Experience and knowledge in the medical device industry
- A self-confident person and a quick learner.
- Very good knowledge (mandatory requirement) of 21 CFR 820 (QSR) and ISO 13485 (They must be able to present our QMS to auditors and inspector and demonstrate the compliance).
- Previous experience with notify body audits.
- Good knowledge on GMP particularly on Medical Device regulations
- Provide guidance and direction to Quality, Production, Distribution and Supply Chain staff in regards to compliance with quality policies, standards and procedures.
- Fluent English speaker is a must. French or Dutch speaker is a plus but not necessary
Education and Experience
- University or Bachelor degree in Pharmaceutical sciences, Process Technology, Engineering or equivalent
- 3 years of professional experience in QA and GMP environment
- Relevant experience in Equipment or Automation Validation
- Additional experience with Non-Conformances, CAPA's and Change Control
Skills and Knowledge
- Expanding knowledge of GMP, equipment and automation/validation, computer compliance
- Good attention to detail and excellent writing skills
- Effective communication skills at multiple levels and areas (inside and outside of Quality)
- Good decision making skills and ability to apply risk based approach.