- Definition of required Qualification and Validation strategies for different Computerized Systems: Manufacturing Equipment, DCS, PLC, MES, Analytical equipment and Software;
- Ensure the Computerized Systems are in compliance with industry standards, guidelines and internal company procedures;
- Preparation of Validation and Qualification Documentation: VP, URS, Test Protocols and Scripts and Validation Reports;
- Execution of Validation and Qualification testing;
- Evaluation and revision of supplier documentation: design documentation;
Participation in Continuous Improvement of Validation processes and procedures;
- Creation of Validation and Qualification SOPs and templates.
-Academic background in Pharmaceutical, Biotechnology, Chemical, Biology and other similar sciences;
-Minimum 3 years of relevant experience in Qualification and Validation for the Pharma and/or Medical Devices Industry;
-Extensive knowledge of GAMP 5, Eudralex Annex 11 and 21 CFR part 11;
-Knowledge of the US and/or European requirements: CFR – Title 21, Eudralex Vol.4, ICH and ISO guidelines;
-Knowledge of Data Integrity principles and Risk Management tools will be desirable.
-Fluent in English (mandatory);
-French/German/Spanish is a plus;
-Autonomy and Good communication skills;
-Goal-driven work capacity;
-Capacity to adapt to different cultures and environments;
-Available for international projects in Europe.
Nível de formação :
3 anos de Ensino Universitário Linguas :
– Sem informação de empresa disponível...