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Specialist QA
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he Quality Assurance Specialist is responsible for providing Quality oversight and ensuring compliance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (cGLP), and applicable regulatory requirements for clinical and commercial drug substance (API) operations. This role supports manufacturing, quality systems, audits, and new product introductions (NPI) while promoting compliance and continuous improvement.

Requisitos:
 Requirements:
 Requirements Educational background in Life Sciences and/or Engineering. Expertise in Quality Systems, including Deviations (Non-Conformities), CAPA, and Change Control. Experience with key electronic systems, such as documentation platforms (e.g., CDOCS), Maximo, TrackWise, LIMS, MES/electronic batch record systems, and SAP. Experience in computer systems validation (CSV) or computer systems quality assurance, including consulting-level technical proficiency. Experience with validation of GxP applications, including Validation Master Plans, GxP risk assessments, IQ/OQ/PQ protocols, test scripts, and summary/approval reports. Robust knowledge of manufacturing and distribution processes, including QA, QC, and Process Development operations. Validated experience serving as quality contact for complex projects involving packaging, inspection, commissioning, qualification, and new drug substances/products. Strong organizational skills, with the ability to drive assignments through



Requiere Mucha Experiencia Requires Expert

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Empleos en Puerto RicoJobs in Puerto Rico
QRC GROUP LLC

Empleos en Puerto RicoJobs in Puerto Rico Ingenieros
Juncos PR 00600 Juncos
DescripciónDescription he Quality Assurance Specialist is responsible for providing Quality oversight and ensuring compliance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (cGLP), and applicable regulatory requirements for clinical and commercial drug substance (API) operations. This role supports manufacturing, quality systems, audits, and new product introductions (NPI) while promoting compliance and continuous improvement. Requisitos Requirements Requirements Educational background in Life Sciences and/or Engineering. Expertise in Quality Systems, including Deviations (Non-Conformities), CAPA, and Change Control. Experience with key electronic systems, such as documentation platforms (e.g., CDOCS), Maximo, TrackWise, LIMS, MES/electronic batch record systems, and SAP. Experience in computer systems validation (CSV) or computer systems quality assurance, including consulting-level technical proficiency. Experience with validation of GxP applications, including Validation Master Plans, GxP risk assessments, IQ/OQ/PQ protocols, test scripts, and summary/approval reports. Robust knowledge of manufacturing and distribution processes, including QA, QC, and Process Development operations. Validated experience serving as quality contact for complex projects involving packaging, inspection, commissioning, qualification, and new drug substances/products. Strong organizational skills, with the ability to drive assignments through

Requiere Mucha Experiencia Requires Expert
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INGENIEROS
Ingenieros (Ingenieros - Otros) Engineering (Engineers - Others)
Sra Maldonado Galeria


AVISO de ClasificadosOnline
Los patronos NO le piden dinero ni un depósito para trabajar, si lo piden es un negocio, inversión o Fraude.
NO envíe dinero para trabajar, tampoco ofrezca información personal, por teléfono o email. Evite el Fraude ClasificadosOnline Warning
Employers DON'T ask for money or deposits for work, if they do is a bussiness, invertion or Fraud.
DON'T send money for work, neither offer personal information, by phone or email. Avoid the Fraud

Empleos en Puerto RicoJobs in Puerto Rico
QRC GROUP LLC

Empleos en Puerto RicoJobs in Puerto Rico Ingenieros
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