Specialist Qa

Job Description Specialist QA with expertise in Quality Systems such as Deviations (Non-conformities, CAPA, and Change Control).
Experience in Facilities, Equipment and Utilities Validations.  Skills: 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, facility, utility, and equipment qualifications.
Enhanced skills in leading, influencing and negotiating with the ability to interact with regulatory agencies and evaluate compliance issues.
Requirements Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience years of directly related experience (Sciences or Engineering) Bilingual (Spanish/English)(Write/Speak) Computer Literacy Requirements Bachelor in Sciences