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.