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Description
Quality Specialist (QSystems) REFª 03.2026_Quality Specialist (QSystems) Location: our site in Lisbon, Portugal Your main responsibilities and tasks: .Ensure compliance support to relevant applicable regulations, guidelines and standards; .Assure accurate and efficient preparation / revision of data and documentation within agreed timeframes; .Ensure that the calibration and qualification of equipment is carried out on time and in accordance with applicable standards and specifications; .Coordinate, plan and execute budgets and Metrology, Qualification and Validation activities, in cooperation with other departments; .Prepare and review documentation, statistical data analysis, protocol and reports issue, according to the systems implemented, for internal use and for regulatory purposes; .Responsible for issuing of annual plans in the Project & process department (calibration, QC maintenance, Solids, liquids, utilities, ointments, Requalification, QC.); .Give support on training to end users with the several Quality Systems available, namely the documentation and deviation management IT systems; .Collaborate in process validation and cleaning activities according to specific training; .Check and approve reports of Equipment Qualification (IQ/OQ/PQ).
Report any deviation detected; Participate Manufacturing Process Validation and Cleaning Validation, and CPV; .Support all activities related to the Quality Department (e.g.: documentary system, deviations, complaints, internal and external audits, training sessions, PQRs, etc.); .Support the definition / implementation of CAPAs and conducting audits (internal and external).
Minimum Requirements: .Degree in Mechanical engineering, biotechnological engineering, Chemistry, equivalent, or related technical field; .Minimum 5 years experience in operation function within the pharma industry or similar industry (i.e. food, medical devices); .Fluent in English and Portuguese (written and verbally); .Strong understanding of GMP requirements for Pharma Industry; .Good working knowledge of GAMP 5, 21CFR part.11, ISO2859, ISO14644; .Good working knowledge of IT Systems such as eDMS, LIMS, TRACKWISE.
What We Offer
.Progression and growth in our group .Cantine .Health insurance .Life insurance .Pension Plan .Private parking on site Reference: Refª 03.2026_Quality Specialist (QSystems) Submit your application using the link: https://career.cordenpharma.com/pt/p/lisbon/jobs/20803/quality-specialist-qsystems Partilhar #my_centered_buttons { display: flex; justify-content: center; } Guardar Oferta  Receber Alertas por Email  Comunicar Problema / Queixa
Weather on start day
Tuesday, 24 de February — Partly cloudy · Max 17° · Min 13° · Rain 10% (0mm) · Wind 17 km/h
Previsão para os dias seguintes
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Wed, 25 FebShowersMax 18° · Min 14°
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Thu, 26 FebPartly cloudyMax 21° · Min 12°
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Fri, 27 FebShowersMax 16° · Min 12°
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Sat, 28 FebPartly cloudyMax 16° · Min 11°
Detalhes
- Listing type
- Job Offer
- Schedule Type
- Full-time
- Category
- Jurídico
- Status
- —
- Location
- Lisboa
- Start
- 19/02/2026
Salário de Mercado
€1 801 - €3 266/mês