Quality Assurance Technician

Há 5 dias


Lisboa, Portugal Somai Pharmaceuticals Lda Tempo inteiro

The QA technician reports to the QA Manager and is responsible for implementing quality activities ensuring high quality processes and products meet customer expectations while maintaining compliance with cGMP applicable regulations, as well as company policies and QMS procedures.

**MAIN RESPONSIBILITIES**:

- Implement QA policies, programs and procedures associated with safety, quality, and regulatory compliance
- Work with all the departments to prevent process or product failure by focusing on continuous improvement of product quality.
- Perform and monitor of actions within the Quality System appropriate to the maintenance and improvements of processes and product quality
- Support master batch documentation review and issuance
- Issue, review, and control documents such Protocols & Reports related to validation processes (cleaning and process validation).
- Register, participate, and control QA processes (Change Control; Supplier qualification; Deviations; Complaints; Internal and External Audits)
- Writing, reviewing, and distributing Quality System Documents (SOPs/documents related to compliance with the GMPs)
- Follow up on multiple projects and assignments
- Meet the KPIs defined for the QA area
- Experience in equipment qualification and in software validation (CSV), protocols, tests and reports are a plus.

**REQUIREMENTS**:

- Degree in Pharmaceutical Sciences or in similar Chemistry / Health Sciences fields.
- Minimum 3 years of experience in quality assurance in the area of Quality
- Excellent Knowledge (training and experience) in Quality Assurance Systems and GMPs
- Knowledge of Document Management software’s; ERP software; Excel Spreadsheet and Word Processing software; QMS systems, SPC and statistics will be positively appreciated.
- To Keep up to date on the latest technologies
- Synthesis and fluent communication skills in Portuguese and English
- Motivation to come on board in an excellent project and team.

**Tipo de oferta**: Integral/Full-time

**Benefícios**:

- Cartão/Ticket refeição

Horário de trabalho:

- De segunda à sexta-feira
- Turno de 8 horas

**Experiência**:

- técnico de Garantia de Qualidade: 2 anos (preferencial)



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