It Validation Engineer - Es Madrid Indiferente

IT VALIDATION Tasks & Responsibilities Provide technical support to computerized information, automation systems used to manufacture, process, package and hold Active Pharmaceutical Ingredients API, bulk, intermediates, and finished drug products. Responsible for writing and reviewing of applicable SOPs to computerized information and automation systems. Identify and implement process improvement in the area of automation. Lead the validation activities of computerized information, manufacturing automation systems that store GMP data, and/or control GMP processes and/or control GMP activities. Ensure the automated system in in compliance with the ALK procedures and applicable regulations. Administration of computer automation systems equipment and software: preventive maintenance and equipment calibration, security administration physical, network, application and data, Backup/Archival, Recovery/Restoration, and Record Retention. Perform the on-going monitoring practices for determining the operational health/fitness and status of automated systems and for assessing whether corrective actions/follow-up activity including changes to hardware, system software, and/or configuration items. Identify and implement process improvement in the area of automation. Perform computerized system decommissioning when a system must be replaced by a new system, retired or taken out of production use. Provides computerized system overview during audits & inspections and collaborate in the preparation of responses and drives follow up of correction actions from audits internal and external. Required qualifications in pharmacy, engineering, chemistry, biology or equivalent Minimum 3 years of experience in computerized information, automation systems within Pharmaceutical industry Master in Computer System Validation GAMP, 21CFR, Part11, EU GMP Annex 15, etc Must have technical knowledge on computerized systems. Must have above average written and verbal communications skills. Demonstrated creative problem-solving and critical thinking skills. Capable of developing novel yet fir for purpose approaches or solutions. Must have excellent interpersonal skills. Good organizational skills and attention to detail. Proven ability to collaborate in a team while completing projects respecting deadlines. Need to be agile and adapt project priorities and deadlines. Ability to work independently with all levels of the organization is required.

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