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 - Indústria Farmacêutica, S.A., procuram integrar um(a) novo(a) colaborador(a) na equipa.
As principais funções a desempenhar serão:
Assegurar a adequada limpeza e higienização das instalações, infraestruturas, equipamentos e utensílios ;
Executar as operações de limpeza utilizando métodos, equipamentos e detergentes especificados, e proceder ao registo de limpeza em conformidade;
Garantir e executar o adequado armazenamento e identificação de cada tipo de resíduo.
Experiência em funções similares; (preferencial)
Zona de residência próxima de Mortágua (fator preferencial);
Sentido de responsabilidade;
Capacidade de trabalhar em equipa;
Disponibilidade para trabalhar por Turnos
Os Laboratórios BASI - Industria Farmacêutica, procura integrar um Operador Logístico no seu departamento de Logística.
Funções:
Perfil:
Tipo de oferta: Tempo Inteiro
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 Research & Development team.
Research & Development Specialist
Job Description:
- Developing and optimizing new formulations, products and manufacturing processes;
- Independently manage research projects including project research plan and budget;
- Support collaborations with external partners for non-clinical and clinical trials;
- Write technical documentation related to product development and commercial launch;
- Supporting and documenting the area of research, galenic, pilot and transposition trials for the industrial process.
Profile:
- Graduation or Master Degree in an area relevant to the function;
- Fluent English (spoken and written);
- Knowledge of Good Manufacturing Practices, Guidelines and Standards;
- Solid experience in product handling/development;
- Experience with injectables, liquids and semissolids;
- 2 year in similar or relevant functions to the function performance.
Envie o seu CV para: recrutamento@actradia.pt
Laboratórios BASI – Industria Farmacêutica S.A. seeks to integrate a new employee into its Research & Development team, for the Development and Analytical Validation sector.
Method development Analyst
Job Description:
- Developing, optimizing and validating analytical methods;
- Preparing descriptions of methods of analysis and analytical validation documentation of finished product and raw materials;
- Performing finished product analysis and development and analytical validation;
- Performing calibrations and internal verification of the section’s equipment.
Profile:
- Graduation or Master Degree in an area relevant to the function.
- Fluent English (spoken and written)
- Knowledge of Good Manufacturing Practices, Guidelines and Standards;
- Minimum 1 year in similar functions
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)
Laboratórios BASI – Industria Farmacêutica S.A.,
in Mortágua (Viseu-Coimbra), seeks to integrate a new employee into its Regulatory/product management team:
PRODUCT MANAGER / REGULATORY AFFAIRS
Main responsabilities:
- Analyzing and submitting (to the Competent
Authority) of the necessary regulatory variations in order to ensure that the
product is commercially available on the market in accordance with mandatory
legal requirements.
- Following the product life cycle ensuring that it is
in compliance and updated with current legislation.
- Collaborating in the process of manufacturing
transfers, ensuring the process’s conformity both at the level of
specifications and at the regulatory level, in order to implement the product
in the Organization in compliance with pre-established targets.
- Ensure that technology transfers and product
launches are carried out in accordance with company planning and comply with
legal and technical requirements and product quality assurance.
- Following Market Access related
activities such as: monitoring product stock-out, beginning/ ending of
commercialization of product, prices and reimbursements
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 your CV to: recrutamento@actradia.pt
Manufacturing Responsible - Injectables Preparation Unit
FUNCTION’S MISSION:
Coordinating and supervising the manufacture of SVP and LVP products, ensuring process quality according to the requirements of Good Manufacturing Practices, legal requirements, guidelines and internal policies and ensuring the productivity, efficiency of the operations carried out and the fulfilment of the established objectives, distributing the tasks required by the preparation teams (IPRP) teams.
SPECIFIC RESPONSIBILITIES:
- Ensuring that products are manufactured according to the established specifications and standards (Batch Manufacturing Record and Standard Operating Procedures)
- Supervising the manufacturing steps, namely the weighing, mixing and filling steps, ensuring compliance with regulations, GMP requirements, internal procedures and instructions.
- Coordinating the activities and the distribution of tasks by the manufacturing team's employees in order to ensure compliance with the production plan.
- Monitoring and ensuring compliance with weekly IJM planning.
- Monitoring, controlling and ensuring compliance with all defined KPIs for his area.
- Preparing and approving procedures and instructions related to manufacturing operations and ensuring their strict application.
- Ensuring that raw materials and primary packaging materials are delivered according to the weekly planning
- Providing training and accompanying the integration and qualification of employees in the sector.
- Conducting the processes of characterization and investigation of deviations, OOS and OOT results
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), preferably in Injectables Manufacturing
- Fluent English (spoken and written)
- 3 years in similar or relevant functions to the function performance
Send us your CV to: recrutamento@actradia.pt
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
Laboratorios BASI - Industria Farmacêutica S.A., in Mortágua, seeks to integrate a new employee into its Medical Affairs team.
Main responsabilities:
Performing Medical writing activities, under the supervision of his superior, such as:
- Elaborating non-clinical modules of MA dossier;
- Elaborating clinical modules of MA dossier;
- Elaborating and reviewing product information (SmPC, package leaflet and labelling)for new products;
- Translating, reviewing and validating technical documents;
Advertising activities, under the supervision of his superior, namely:
- Elaborating advertisement pieces;
- Regulatory Assessment of advertisement pieces;
- Notifying Infarmed about advertisement pieces;
- Preparing individual advertisement sheets;
- Regulatory assessment of support actions and events provided to health professionals;
- Archiving of all relevant information related to events and training events;
- Documenting on the transparency platform the supports provided by the pharmaceutical industry;
- Registering the pharmaceutical sales representatives in Infarmed;
- Regulatory analysis of free samples distribution entity blocks.
Other activities related to market access or scientific issues:
- Performing scientific bibliographic research;
- Researching market access databases;
- Providing internal training for the sales team
Profile: - Master in Pharmaceutical Sciences - Fluent English - Ability to write about technical and scientific issues
Send us your CV to: recrutamento@actradia.pt