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PCI Pharma Services

QA Administrative

PCI Pharma Services León, Castile and León, Spain

Pharmaceutical Manufacturing · 5,001-10,000 employees

Sep 17
qa Junior (0-2 yrs) Full-time Spain
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About the role

The QA Administrative role involves developing quality systems in accordance with ICH guidelines and preparing Standard Operating Procedures following GMP regulations. Responsibilities also include managing quality documentation, reviewing batch records, and assisting in internal and external quality audits.

What they look for

Quality Assurance GMP Compliance Documentation Control Standard Operating Procedures ICH Guidelines Quality Audits Regulatory Compliance Data Management Quality Records Management Supplier Claims Labeling Control

Requirements

The candidate is expected to perform duties according to company quality standards and safety criteria. The role requires a focus on documentation accuracy and adherence to established behavioral and quality protocols.

Full description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI. 

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

   

·        Colaborar con los Técnicos de Garantía en el desarrollo del sistema de calidad de acuerdo a lo definido en las guías ICH Q7, Q8, Q9 y Q10.

·        Elaboración de Procedimientos Normalizados de Trabajo siguiendo las normativas GMP.

·        Emisión y revisión de los boletines de análisis.

·        Control de la documentación, de los datos y registros generados y archivo de la documentación de los lotes. Control del etiquetado.

·        Gestión y aprobado de los registros de calidad.

. Revision de APR

·        Reclamaciones a proveedores.

·        Realización de las auditorias de Calidad (internas, externas o de clientes), siempre con supervisión de un Técnico de Garantía de Calidad.

·        Trabajar siguiendo principalmente criterios de seguridad laboral.

·        Desempeñar sus funciones siguiendo los criterios de calidad marcados por la Compañía.

·        Realizar las funciones de su puesto atendiendo a los criterios comportamentales establecidos por la Administración por Valores.

 

 

 

 

 

 

 

 

 

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

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