Our client is a reference company in the pharmaceutical industry that wants to integrate a Quality Assurance Specialist. The job will be in their offices in Oporto.

Principais responsabilidades

This person will be responsable for:

• Assure the respect of the GMPs and Health Authorities requirements at local level;
• Contribute in maintaining the local quality system as per GMPs and corporate guidelines;
• Fill in the KPI files;
• Review of batch record;
• Registration and archive of the documentation at local level;
• Redaction and review of SOPs, records, protocols and reports according to GMPs, National/ Corporate Guidelines and health authorities requirements;
• Review of logbook;
• Redaction of APR according to the calendar;
• Execution at local level of staff GMP training;
• Assuretheescalation to theQualityAssuranceManagerin case ofcriticalissues;
• Participate to the self-inspections as per approved annual plan and to the external audits (Health Authorities, Certified Bodies, Supplier);
• Support in redaction of out of specifications, out of trend, deviations, CAPA, change controls, complaints and record them in logbook according to cGMP and reference SOPs;
• Support the manufacturing site during external quality inspections;
• Support at local level the Qualified Person/Quality Assurance Manager.

Perfil desejado

The ideal profile should have:

• Master's Degree in Pharmaceutical Sciences (mandatory);
• Minimum of 2 years of experience in Quality Deputy and Quality Assurance (mandatory);
• Title of Qualified Person (mandatory);
• Good communication skills (verbal, written and presentations);
• Fluency in English (oral and written);
• Good interpersonal skills;
• Analytical sense and a solid understanding of research methodology;
• Solid Computer skills.

Benefícios adicionais

Opportunity to integrate a challenging project in the healthcare area.