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3 semanas atrás
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
- Quality Specialist - CAPA Implementation
Qualifications:
- Bachelor's Degree in Engineering or Science Field
- Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries.
- Must be fully bilingual (English / Spanish) with excellent oral skills.
- Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
- Experience with CAPA processes.
- Knowledge of systems such as: Windchill, Ecapa, MES, or BMRAM.
- Experience in risk management and line clearance.
- Experience with change assessments, process validations, ESQ and software validations.
- Previous experience with quality assurance (required).
- Available to work extended hours, possibility of weekends and holidays.
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