Specialist QA - Juncos - Administrative shift-34374
Specialist QA - Juncos - Administrative shift-34374
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5years
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- Expertise in Quality Systems such as Deviations (Non-conformities CAPA and Change Control).
- Hands on experience in electronic systems for instance: Documentation platforms (CDOCS) Maximo Trackwise LIMS electronic batch record (MES) and SAP
- Experience with Validation of GxP applications Validation Master Plan Installation Qualification (IQ) Risk Assessment/GxP assessment Operational Qualification (OQ) and Performance Qualification (PQ) Protocols Test Scripts and Completion/Summary Reports approvals as per the compliance requirements.
- Validated experience as Quality Contact for sophisticated projects involving new drug substances /products with experience in commissioning and qualifications.
- Enhanced skills in leading influencing and negotiating with the ability to interact with regulatory agencies and evaluate compliance issues.
- Strong communication (both written and oral) facilitation and presentation skills. Fully Bilingual in English and Spanish.
Requirements
Employment Type
Full Time
