Regulatory Compliance Specialist
2 weeks ago
About the Role:
We are looking for a skilled and motivated Quality Engineer for production who has a natural interest in making QA a value-adding support for the business, mainly production, but also Engineering and R&D Projects.
The position is temporary for 6 months with the possibility for extension. As a Quality Engineer Consultant, you will be responsible for key assignments such as CAPA process, validation, documentation, and case handling. This includes batch release and complaint handling.
The ideal candidate will have a strong background in quality assurance, with experience in implementing and maintaining quality policies, procedures, and standards. Responsibilities will include developing and maturing QA processes, particularly in complaint handling, deviation/CAPA, and batch release.
Key Accountabilities:- Develop and mature QA processes with specific focus on Complaint handling, Deviation/CAPA, and batch release.
- Excel in communication and thrive as an ambassador for Quality in the organization.
- Bring know-how and expertise to the full end-to-end process.
- A degree in engineering or life sciences.
- Working knowledge as QA for production and/or engineering.
- Understanding of industry standards such as GMP or ISO.
- Experience in working in regulated industries.
- Flair for technical aspects in production and quality documentation systems.
- Good communication capabilities.
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