Qualification and Validation – Assistant

Há 4 dias


Lisbon, Portugal Recipharm Tempo inteiro

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 – Assistant

Mission:

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 area 2 years experience in Pharmaceutical Industry GMP knowledge Know-how of CSV requirements according to FDA 21CFR part 11/ EUGMP Annex 11 regulations and ISPE GAMP 5 guidelines Fluent in English Team player Problem 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 systems Operational handling of management of Deviations, CAPAs and Change Control activities Creation and revision of procedures related with equipment’s, facilities and computerized systems Update of the asset management software Self-dependent way of working and taking ownership of assigned task to plan and deliver according to agreed timelines Facilitator between different departments: Production, QC and Maintenance

 If you are interested in this position, send your application to recursos.humanos@genibet.com


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