QA / QC Specialist
2 weeks ago
Eupry Copenhagen, Capital Region of Denmark, Denmark
Eupry is a leader in temperature monitoring solutions for GxP industries, ensuring compliance with Good Distribution Practice (GDP), Good Manufacturing Practice (GMP), and Good Laboratory Practice (GLP) requirements. We are seeking a dedicated and detail-oriented QA / QC Specialist to join our team and support our mission of delivering high-quality, compliant solutions.
Key Responsibilities:
- Maintain and continuously improve our Quality Management System (QMS) to ensure compliance with ISO 9001, ISO 17025, ISO 27001, and ISO 14001, as well as GxP regulations
- Respond to internal and external quality-related questions and questionnaires, ensuring alignment with regulatory expectations
- Validate internal and external products and systems to meet GxP requirements, primarily following GAMP5 guidelines, ensuring data integrity and compliance in all processes
- Manage and handle Corrective and Preventive Actions (CAPAs) across the company to enhance efficiency and compliance in operations
- Plan, execute, and document internal audits to maintain regulatory adherence and support continuous improvement
- Author, review, and update internal Standard Operating Procedures (SOPs) and quality documentation to ensure compliance with industry requirements
- A background in Quality Assurance, Quality Control, or a related field (Engineering, Life Sciences, or similar preferred)
- Experience working with Quality Management Systems and regulatory compliance in GxP environments is preferred
- Knowledge of any ISO standards (ISO 9001, ISO 17025, ISO 27001, ISO 14001) and GxP regulations, especially GAMP5 is preferred
- Analytical mindset with the ability to assess processes, identify gaps, and implement improvements to meet compliance standards
- Excellent communication skills, both written and verbal, to effectively engage with internal teams and external customers
- Experience in CAPA management, risk assessment, and internal auditing is a plus
- Detail-oriented, proactive, and capable of working independently as well as collaboratively within a compliance-driven environment
- A dynamic and collaborative work environment in a company dedicated to compliance and innovation in GxP industries
- Opportunities for professional development, training, and continuous learning in regulated environments
- The chance to contribute to high-quality standards in an organization that prioritizes compliance, quality, and customer trust
- A friendly workplace with a growth mindset
- Opportunity for getting a lot of responsibility within your field.
If you are passionate about quality and regulatory compliance and want to be part of a company that is in rapid growth, we would love to hear from you
Seniority levelAssociate
Employment typeFull-time
Job functionQuality Assurance
IndustriesIT Services and IT Consulting
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