IT Quality & Compliance (PHARMA COMPANY)

Importante compañía farmacéutica busca un/a Project Manager de Validaciones IT.
Your new company

Important pharma company is looking for an IT Compliance expert.

Your new role

A key role in the IT & Digital Transformation team, accountable to ensure infrastructures and software applications are delivered and maintained in compliance with applicable regulations and Company policies and procedures. This position will be involved in multidisciplinary projects of the scientific and industrial areas both at local and global level, leading the validation strategy and ensuring compliance with GxP regulations of computerized systems. The position will also support audits and inspections as well and activities required to ensure the validation status is maintained, and will the evolution of the IT Quality Management System. The collaboration with the internal and external stakeholders is key for this position

What you'll need to succeed

Be an internal and external IT Compliance expert, collaborate with internal operations and third-party vendors to ensure computer systems complies with relevant regulations. Liaises with business quality in regard to data integrity and validation process governance. Evaluate the regulatory impact of each computer system and the need of validation Define validation/qualification strategy and provide advice, guidance on validation activities in collaboration with Business Quality and project teams following a risk-based approach. Plan, organize and coordinate the activities of the validation projects of Computer Systems in Company. Participation in the revision and follow up of deviations related with validation projects and establishment of suitable corrective measures. Ensure validation and project life cycle documentation fulfils Company standards: Validation plan, user requirements, and design revision, risk analysis, IQ, OQ, PQ protocols together with the corresponding reports, traceability matrix and residual risks, data integrity assessment, etc. Ensure periodic activities are conducted maintain the validation status. Continuous improvement of IT Compliance policies and procedures and alignment with current applicable regulations. Support the internal and external audits. Be actively involved attending the auditors requirements and provide documentation, evidences or answer questions. Perform internal reviews to ensure IT Compliance policies and procedures are followed and that the systems are in continuous compliance/validation status in accordance to regulations. Provide guidance and oversight for the management of CAPA related to Computerized Systems and IT QMS. EDUCATION: University Science Degree (Chemistry, Biology, Pharmacy, Engineering, computer science or comparable) SPECIFIC KNOWLEDGE 5+ years in Computerized Systems compliance in regulated environments such as Pharmaceutical/ biotechnology/Chemical industry Experience with Industrial processes/solutions is a differential Experience with Risk Management, Auditing, Project & Application management, compliance of computerized systems (e.g. GxP, SOX). Knowledge of current Data Integrity standards and requirements for the pharmaceutical, validation lifecycle and GxP regulations Experience in a global and multicultural environments is a differential

What you'll get in return

Salario Fijo Contrato indef con el cliente final Flexibilidad de entrada: 7:30-9:30 Viernes se puede salir a partir de las 15.30h Teletrabajo hibrido. 50% días al mes (10) Retribución Flexible para Mutua Medica – subvencionado Dias extra de vacaciones en: Sem Santa, Navidades, Puentes (además de los días de vacaciones normales)

What you need to do now

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career. #1078819
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Resumen

Tipo de trabajo
Permanente
Industria
Farmacéutica
Lugar
Barcelona
Sector
Technology
Salario
A considerar
Ref.:
1078819

Hablar con un consultor

Hablar con Selena Sabiote, la persona que lleva esta posición, en la oficina de Barcelona
Hays Barcelona, Calle Valencia 307 - 313

Teléfono: 934670324