Quality Validation Specialist en PIVOTAL

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Quality Validation Specialist

Fecha de la oferta: 14 May.
Empresa que publica esta oferta: PIVOTAL
PIVOTAL es una CRO (Clinical Research Organization), líder en el sector de Ensayos Clínicos y Consultoría Farmacéutica en España con más de 150 empleados y oficinas en Madrid y Barcelona y empleados en Francia,Italia, Alemania y Reino Unido.

Somos una compañía dinámica, joven y creativa, ofrecemos a nuestros clientes la máxima calidad, excelencia, creatividad y cumplimiento en nuestros compromisos profesionales tanto a nivel nacional como internacional. Nuestro portfolio de clientes cuenta con las compañías farmacéuticas y biotecnológicas más importantes del sector.
Únete al equipo de Pivotal!
Número de vacantes: 1
Provincia/s: Madrid

Descripción

Descripción: The Quality Validation Specialist will work closely with the Information Technology Department to plan, organise and perform qualification, validation for defined applications, systems, and processes that meet Pivotal high-quality standards.
Description/Primary Responsibilities
• Work with the Quality Assurance & Compliance Director: this role will provide customers´ specific validation services to meet the internal customers´ requirements
• Deliver and manage compliance projects focused on Computerised Systems Validation (GAMP 5 methodology and Data Integrity assessment/remediation)
• Develop and write qualification and validation documents following established standards and templates, including but not limited to the following:
o System description
o Qualification/Validation Protocols and Summary Reports
o Test Scripts
o Standard Operating Procedures
o Risks/Impact Assessments
o Specifications (URS/FRS/DDS)
• Perform and assist with qualification/validation protocols for systems and applications in compliance with Pivotal policies and procedures and industry guidelines in the performance of validation activities, such as IQ/OQ/PQ and others
• Stay current with related industry trends and regulations. Areas of internal services may include Computerised Systems Validation, Audit Assessments, Custom procedure development, and Data integrity assessment and remediation
• Knowledge of US FDA part 11 and European Commission Annex 11
• Draft Standard Operating Procedures and other documents needed to support electronic systems use ensuring internal users training processes
• Work with the Quality Assurance & Compliance Unit´s staff to troubleshoot, correct and prevent non-conforming processes
• Develop and document written SOPs, as required, for current validated systems and applications
• Implement document changes and control procedures
• Conduct deviation investigation and resolution of problems and issues encountered during field execution activities
• Perform other varied duties, as assigned

Tipo de contrato: Indefinido

Requisitos

Requisitos: Minimum Requirements
• Education: Bachelor of Science in Engineering is required for an Engineer; Bachelor of Science in a related field is required for a Validation Specialist. Non-BS degrees will be evaluated on a case-by-case basis
• Minimum of 3-5 years of experience in Pharmaceutical, Biotech, Medical Device, Commissioning or Validation with direct experience in process, and electronic systems validation. Preferred a minimum of 2-3years relevant industry experience with a portion of that experience in Clinical Research. Experience in writing and execution of IQ, OQ and PQ protocols and reports for GXP Systems and Software
• Proficient with computers and related softwares (Microsoft Office Professional)
• Familiarity with related GXP procedures and requirements. Including knowledge of appropriate Quality Systems and GCP requirements (FDA, EU, ICH) with the ability to assess compliance risks
• Knowledge of validation methodology
• Familiarity with data acquisition systems and protocols
• Excellent oral and written communication as well as interpersonal skills
• Ability to work independently and as a team member
• High energy, enthusiastic self-starter who can work with minimal supervision
• Ability to manage multiple concurrent tasks/studies
• Well organised and details-oriented
At Pivotal S.L. we offer excellent compensation and benefits programmes that reflect our goal to be a competitive and supportive employer.
Nivel de estudios mínimo requerido: Licenciado
Idiomas requeridos: Inglés nivel Alto.
Experiencia profesional mínima requerida: 3 años
Disponibilidad para viajar requerida: El 20% del tiempo laboral

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