As informações recolhidas no âmbito da sua candidatura serão arquivadas informaticamente e utilizadas exclusivamente para eventuais processos de recrutamento ou seleção que possam surgir no Grupo FHC. Em conformidade com as disposições legais em vigor, são garantidos ao candidato o direito de acesso aos seus dados, respectiva rectificação e eliminação, devendo utilizar para o efeito o e-mail: recursos.humanos@actradia.pt.
Os
Laboratórios BASI - Industria Farmacêutica, S.A., em Mortágua, procuram
integrar na seu departamento da Direção Industrial - Operadores de Produção (m/f):
Funções:
- Executar tarefas indiferenciadas
- Trabalho em
linha de enchimento e/ou embalamento
- Recepção, verificação e pesagem dos materiais
- Preenchimento da documentação associada
- Conhecer e aplicar as normas associadas às Boas
Práticas de Fabrico
Perfil:
- Disponibilidade para turnos
- Experiência anterior em Industria Farmacêutica (preferencial)
- Pessoa rigorosa
Envie o seu CV para: recrutamento@actradia.pt
Os Laboratórios Basi - Indústria Farmacêutica, S.A, em MORTÁGUA, procuram integrar um(a) Analista Químico Adjunto.
As principais funções a desempenhar serão:
• Assegurar o cumprimento dos ensaios que lhe são atribuídos, participando no cumprimento do plano de trabalho;
• Efetuar análises a matérias-primas, produto intermédio e produto acabado;
• Assegurar o correto armazenamento de materiais no Laboratório e uma correta gestão de stocks (registo de entradas, saídas, transferências de armazém, etc.);
• Identificar e comunicar necessidades de aquisição de material, consumíveis e equipamentos do laboratório;
• Acompanhar a implementação de metodologias eficazes de limpeza de material de laboratório e infraestruturas e assegurar a sua validação ou eficácia;
• Cumprir com as boas práticas de conduta no Controlo de Qualidade, incluindo procedimentos internos;
• Conhecer e aplicar as normas associadas às Boas Práticas de Fabrico.
Requisitos:
• Licenciatura/Mestrado em Química/Bioquímica/Biotecnologia ou outras áreas relevantes
• Experiência na Industria Farmacêutica
• Inglês fluente
Laboratórios BASI
– Industria Farmacêutica S.A. seeks to integrate a new employee into its
Quality Control team.
QC Planning and
Support – Technical Support
FUNCTION’S MISSION:
Ensuring the
compliance of CQ documentation, preparing and making available to analysts the
information they need to conduct the analyses and evaluate trend of results to
contribute to the improvement of the department.
RESPONSIBILITIES:
Collaborate in the
training and information of the collaborators in the QC, on suitable laboratory
methods, QC procedures and techniques.
Evaluate Change
Controls & CAPA with impact on QC (includes new products, new MPs, changes,
etc.), under occasional supervision.
Evaluate Authority
Requests within QC and plan and prepare timely response, under occasional
supervision.
Participate in the
implementation of improvement projects in quality control.
Analyze and track
OOS / OOT records, according to internal procedures.
Evaluate
specifications and methods in accordance with internal requirements.
Participate in the
preparation and review of the following QC documentation:
· Finished
product and raw material specifications in accordance with regulatory
information
· Technical
analysis instructions
· Analysis
order templates (finished product, stability, product in process, raw
materials, ...
· Stability
Reports (including stability trends)
· Analysis
reduction reports in QC
· IPCs
· Certificates
of analysis
Receive requests
for external services and participate in costing.
PROFILE:
Fluent English (spoken and
written)
Knowledge on chemistry,
classical chemical analytical techniques and analysis instrumental
Knowledge on Good
Manufacturing Practices
Os Laboratórios Basi - Indústria Farmacêutica, S.A, em Mortágua, procuram integrar um(a) Técnico Analista Químico Sénior.
As principais funções a desempenhar serão:
• Assegurar o cumprimento dos ensaios que lhe são atribuídos, participando no cumprimento do plano de trabalho;
• Efetuar análises fisico-químicas a matérias-primas, águas, produto intermédio e produto acabado;
• Assegurar o correto armazenamento de materiais no Laboratório e uma correta gestão de stocks (registo de entradas, saídas, transferências de armazém, etc.);
• Identificar e comunicar necessidades de aquisição de material, consumíveis e equipamentos do laboratório;
• Acompanhar a implementação de metodologias eficazes de limpeza de material de laboratório e infraestruturas e assegurar a sua validação ou eficácia;
• Cumprir com as boas práticas de conduta no Controlo de Qualidade, incluindo procedimentos internos;
Requisitos:
• Licenciatura/Mestrado em Química/Bioquímica/Biotecnologia ou outras áreas relevantes
• Experiência minima de 3 anos em Laboratório (factor eliminatório)
• Experiência na Industria Farmacêutica (preferencial)
Envie o seu CV para: recrutamento@actradia.pt
TÉCNICO SÉNIOR DE LOGÍSTICA/COMPRAS
RESPONSABILIDADES:
- Procurement, negociação e compras.
- Coordenação e acompanhamento de
operações de logística (armazenamento, gestão de stocks e transportes).
- Planeamento de necessidades de
compras de acordo com os planos de fabrico.
- Mapeamento e otimização dos processos de Logística/ Compras.
PERFIL:
- Licenciatura/Mestrado em Engenharia
Industrial, Engenharia de Processos, Logística ou Gestão de Operações
- Experiência em Logística Industrial
- Experiência em GDP/ GMP / Ferramentas
de melhoria contínua
- Bons conhecimentos de Inglês
- Bons conhecimentos informáticos (ERP, Excel avançado)
FUNCTION’S MISSION:
Coordinating, managing and distributing the tasks required by the Preparation, Filling and Weighing teams of the Liquids and Semi-Solids section according to the established daily schedule.
SPECIFIC RESPONSIBILITIES:
- Coordinating the activities and the distribution of tasks by team's employees in order to ensure compliance with the production plan.
- Monitoring the production of the batch by monitoring the weighing, preparation and filling activities, ensuring its correct execution and compliance with procedures and instructions.
- Setting up the equipment parameters to start the production of the batches.
- Approving line clearances, validating the variable data marking and filling masses to start production.
- Verifying all critical parameters of the manufacturing process according to ITP (production instructions).
- Performing routine and format change tunings on the filling equipment.
- Ensuring the correct completion of Logbooks.
- Following and Promoting the compliance with the Production Plan
- Identifying and resolving equipment alarms.
- Providing training and accompanying the integration and qualification of other collaborators.
- Ensuring the correct completion of production records at the time of their execution
- Communicating the status of production and any occurrences to their superior and other operation shifts and supervisors.
PROFILE:
- Graduation or Master Degree in an area relevant to the function
- Knowledge of Good Manufacturing Practices, Guidelines and Standards
- Experience in the Pharmaceutical Industry (Leading teams)
- Good English Level
- 1 years in similar or relevant functions to the function performance
Send us your CV to: recrutamento@actradia.pt
Laboratórios BASI – Industria Farmacêutica S.A., in Mortágua (Viseu-Coimbra), seeks to integrate a new employee into its Regulatory team:
REGULATORY AFFAIRS OFFICER (m/f)
Main responsabilities:
- Performing registration of the medicines and other health products in the applicable markets.
- Reviewing MA dossier for the Products, ensuring their compliance.
- Preparation of the dossier Modules and Dossier compilation for submission to the Regulatory Authority..
- Providing support to regulatory information requests from the Authority or customers, including MA Dossier compliance analysis and effective response to requests for information.
- Replying to deficiency letters that may arise after review by the Regulatory Authority.
- Contacting the Competent Authorities and Notified Bodies in order to update the status of the processes.
- Providing regulatory support in Licensing of Basi Laboratories products, namely:
• Preparing Dossiers for audits and deficiency letters requests arising from the received reports, under further review and approval by a qualified colleague.
• Monitoring audits feedback and subsequent response to requests arising from the received reports.
- Compiling and evaluating compliance of products and their documentation with all the requirements required by their own legislation for the submission/registration so that they can be placed on the market.
- Evaluating the conformity, according to internal and regulatory requirements, of the artworks, with regard to medical devices, food supplements, biocides, cosmetic and body care products and dangerous preparations.
- Making request for CPP’s, CVL’s, CNP’s, ect. to authorities
- Elaborating and updating security statements, PIF’s, PSDS, ect.
- Updating all the product regulatory information in the control tools in force.
Profile: - Graduation or Master Degree in an area relevant to the function. - Knowledge of Good Manufacturing Pratices, Guideline and Standards - Experience in the Pharmaceutical Industry - 2 years of experience in similar or relevant functions
Send us your CV to: recrutamento@actradia.pt
Laboratórios BASI – Industria Farmacêutica S.A.
seeks to integrate a new employee into its Training & People Qualification team.
Mission:
Guaranteeing that qualified employees have access to the
respective work áreas which have access control.
Responsabilities:
- Defining a corporate strategy for the qualification,
re-qualification and initial and continuous training
- Creating procedures and methodologies for Qualification of
Personnel and ensuring their implementation
- Establishing and implementing a Training and Qualification
Plan to all employees in accordance with their function
- Providing specific initial and continuous training to
employees concerning:
- Visual inspection;
- Clothing and Operation in Aseptic area;
- Personnel Hygiene;
- Good Manufacturing Practises;
- Personnel Qualification;
- etc.
- Providing training and accompanying the integration of new
employees.
- Following and ensuring the compliance with te implemented
Programs of qualification;
- Establishing internal training models and materials and
reviewing and approving all training materials from all departments;
- Conducting internal audits
- Evaluating results os the qualification tests
- Controlling the employees accesses to their work area in
accordance with their function;
- Other general responsabilities.
Profile:
- Graduation or Master Degree in a relevant area to the function
- Fluent English (spoken and written)
- Knowledge of GMP
- Experience in the Pharmaceutical Industry
- Experience in People Qualification
- Leadership and team management skills
MISSÃO
Coordenar e controlar o Embalamento dos produtos líquidos e
semissólidos, assegurando a qualidade do processo de acordo com os requisitos
das Boas Práticas de Fabrico, requisitos legais, guidelines e
procedimentos internos. Garantir a eficiência das operações de acordo com os
objetivos traçados.
FUNÇÕES
- Monitorizar o processo de Embalamento assegurando o cumprimento
dos procedimentos internos e instruções de trabalho;
- Assegurar que os produtos são embalados de acordo com a
legislação atual, com as Boas Práticas de Fabrico, Guidelines e
especificações do produto;
- Elaborar/aprovar instruções de trabalho e garantir a sua
aplicação;
- Analisar/monitorizar processos produtivos de acordo com o
planeamento semanal.
- Definir, recolher e analisar KPI’s da sua área funcional.
- Conduzir processos de caracterização e investigação de
Desvios do sector.
- Gerir stock de consumíveis do sector.
- Gerir os Recursos Humanos, recursos materiais e
equipamentos.
- Providenciar formação, acompanhamento e a qualificação dos
colaboradores do sector.
- Participar na definição dos Planos de Produção de acordo
com as Encomendas e Previsões do departamento comercial.
- Entre outras.
PERFIL
- Licenciatura/Mestrado em área relevante para a Função;
- Experiência concreta na Industria Farmacêutica em cargo semelhante.;
- Experiência em Gestão de Equipas
- Experiência em GDP/ GMP / Ferramentas de melhoria contínua
- Bons conhecimentos de Inglês
- Bons conhecimentos informáticos (ERP, Excel avançado)
Envie o seu CV para: recrutamento@actradia.pt
Laboratórios BASI – Industria Farmacêutica S.A., in
Mortágua (Viseu-Coimbra), seeks to integrate a new employee into its Regulatory
team:
Regulatory Affairs Manager
Main
responsabilities:
- Supervise and manage the Registration team.
- Performing registration of the medicines and
other health products (medical devices, food supplements, biocides, cosmetic
and body care products and dangerous preparations) in the applicable markets.
- Reviewing the MA dossier for the Products,
ensuring their compliance for further review and approval
- Preparing the dossier Modules and compiling the
Dossier for submission to the Regulatory Authority
- Replying regulatory information requests from the
Authority or customers;
- Contacting the Competent Authorities and Notified
Bodies in order to update the status of the processes
- Compiling and evaluating compliance of products
and their documentation
- Making request for CPP’s, CVL’s, CNP’s, etc, to
authorities.
- Elaborating and updating security statements,
PIF’s, PSDS, etc.
- Updating all the product regulatory information
in the control tools in force
Profile:
- Graduation or Master Degree in an area relevant to the function.
- Knowledge of Good Manufacturing Pratices, Guideline and Standards
- Experience in the Pharmaceutical Industry
- 5 years of experience in similar or relevant functions
SEND US YOUR CV TO: recrutamento@actradia.pt