Quality Management System
1 month ago
The Quality Management System & Training Compliance Specialist is responsible for:
- Managing and/or facilitating the identification, documentation, investigation, escalation, tracking, reporting, and closure/follow-up of Quality Events (QEs), Corrective Actions / Preventative Actions (CAPAs), and Effectiveness Checks (ECs) within a GxP Quality Management System (QMS).
- Providing ad-hoc support for broader QM&C activities, both globally and cross-functionally. These responsibilities may include, but are not limited to, assisting in the development/revision of QM&C Department processes/procedures, reviewing, and providing input on cross-functional processes and procedures or Controlled Document Deviations and assisting with the governance, maintenance, and accuracy of QMS documentation / records.
- Assisting in the creation, coordination and reporting of GxP training activities and/or programs for one or more Ergomed Group business entities.
- Supporting the provision of Ergomed CR staff training information/documentation during audits and inspections as it pertains to Ergomed Group.
Qualifications
Bachelor’s degree in relevant field of study and 3-5 years in Quality Assurance or equivalent combination of studies and work experience.
Knowledge of e.g., GCPs, ICH guidelines, FDA 21 CFR Part 11 and other applicable country regulations.
Ability to compile and interpret quality metrics
Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint
Additional Information
We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.
To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.
We offer:
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Training and career development opportunities internally
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Strong emphasis on personal and professional growth
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Friendly, supportive working environment
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Opportunity to work with colleagues based all over the world, with English as the company language
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