Qualification And Validation – Assistant
Há 7 dias
GenIbet is a cGMP biopharmaceutical CMO (Contract Manufacturing Organization) offering highly specialized microbial, cell culture and viral process development and cGMP manufacturing services to research groups, biotech and pharma companies.GenIbet's core activity is the manufacture and supply of materials for use in early-stage drug development, pre-clinical studies and cGMP manufacturing for clinical trials and commercial.
Qualification and Validation – AssistantMission:Support Qualification and Vallidation area mission, from a Quality Assurance perspective, ensuring that instruments, equipment's, systems and facilities are fit for their intended use, fulfil the regulatory expectations and comply with their acceptance criteria's.
Management of equipment's and instruments life cycle through record, organization, revision and archive of the associated documentation, ensuring their compliance with the Good Manufacturing Practices, client's specifications and internal requirements, contributing to the existence of proper quality procedures and guidelines in place, as well as supporting training activities.
Desired profile: BSc or MSc in Chemical, Biological, Mechanical or Industrial engineering or other relevant area2 years experience in Pharmaceutical IndustryGMP knowledgeKnow-how of CSV requirements according to FDA 21CFR part 11/ EUGMP Annex 11 regulations and ISPE GAMP 5 guidelinesFluent in EnglishTeam playerProblem resolution and critical thinking skills Job Description: Prepare, review, and approve technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification/validation documentation)Oversee and support the life-cycle management of validated software systems incl.
change management, periodic review, and system retirement.Support in qualification of equipment's and computerized systemsOperational handling of management of Deviations, CAPAs and Change Control activitiesCreation and revision of procedures related with equipment's, facilities and computerized systemsUpdate of the asset management softwareSelf-dependent way of working and taking ownership of assigned task to plan and deliver according to agreed timelinesFacilitator between different departments: Production, QC and Maintenance If you are interested in this position, send your application to ******
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