Em busca de Entusiasmo? A Galenicum é o seu lugar

A Galenicum Health Brasil é uma empresa em crescimento. Por isso, acreditamos que uma equipe dedicada e entusiasmada é vital para nosso presente e futuro sucesso. Se esta é sua busca, envie seu currículo para:

recruiting@galenicum.com

Posições em aberto

Intellectual Property Expert

Intellectual Property Expert

October 11, 2017

Position in organization:

  • Department: IP
  • Reporting to: IP Manager 
  • Location: Barcelona headquarters ( Esplugues de Llobregat)

Education / experience:

  • Bachelor’s degree in Chemistry 
  • Excellent level of business English and Spanish, spoken and written. Other language skills will be a plus.
  • Excellent computer skills, specifically Excel, Word, Outlook and Power Point. 

Previous experience required:

  • Valuable to have 1-3 years of experience in intellectual property in pharmaceutical industry (Patent drafting and filing procedure in Europe)
  • Strong knowledge of regulations, guidelines and European registration processes.
  • Valuable good knowledge of Good Clinical Practices and international clinical regulatory requirements
  • Knowledge of the drug development process

Roles and responsibilities:

  • Assist in developing the most effective national and world-wide patent strategies and portfolios for company products and projects.
  • Development of patentability, validity, infringement and freedom- to- operate opinions.
  • Prosecution of patent rights, mainly in Europe and USA.
  • Drafting notice of oppositions and representing Galenicum in oral proceedings.
  • Execute patent evaluation reports.
  • Analysis of patents and scientific literature on various development projects.
  • Search in specialized databases/literature and resolution of technical problems.
  • Drafting and filing of patent applications.
  • Respond to IP related queries.
  • Follow IP policies and provide critical and clear IP advice to internal members.
  • Follows Galenicum Safety, Health, and Environmental policies and procedures.

Personal Profile:

  •  Self-sufficient, critical, disciplined, decisive, methodical, confident, hard working, dynamic, creative and proactive.
  • Strong analytical frame of mind and problem solving capabilities. Strong attention to detail.
  • Strong organizational, planning and time management skills, to design, monitor and enforce work plans.
  • Ability to effectively prioritize and execute projects/demands on time in a fast paced environment is crucial.
  • Highly responsible and capable to work under pressure.
  • Good in negotiations. Persuasive and encouraging.
  • Strong interpersonal skills. Supportive and able to build effective working relationships throughout the organization. 
  • Excellent written and oral communication skills
  • Leadership skills 
  • Ability to increase technical knowledge and apply new skills.

QA Manager

QA Manager

September 13, 2017

Position in organization:

  • Department: Quality Assurance  
  • Reporting to: QA Head
  • Staff in charge: 9
  • Location: Esplugues de Llobregat

Education / experience:

  • Degree in Pharmacy
  • Status as a European Qualified Person
  • Excellent level of English and Spanish, spoken and written.

Previous experience required:

  • Minimum of 2 years working in the pharmaceutical industry in a quality management position.
  • Experienced in implementing quality systems in a GMP environment, and direct experience with health authority inspections.
  • Operational GMP experience would be a distinct advantage
  • Preferibly, with previous experience as Qualified Person (Pharmaceutical). QP/Responsible Person should meet the qualification and all conditions provided for by the EU regulation.
  • Extensive knowledge of EU GMP requirements, compliance regulations and pharmaceutical industry practices.
  • Experience MS Office 

Roles and responsibilities:

  • Ensure that all aspects of the handling and distribution of pharmaceuticals products comply with the requirements of the EU Good Manufacturing Practices/ Good Distribution Practices and relevant local regulatory and legislative requirements.
  • Ensure the implementation, maintenance and upgrading of the local Quality System in order  to drive compliance with local/International GDP regulatory requirements and Galenicum global standard operating procedures.
  • Provide quality oversight to GMP/GDP CMO/ vendors particularly such as API suppliers, FP Manufacturers, warehouse/distribution service providers in compliance with Galenicum Quality Standards (qualification, quality agreements, vendor management).
  • Act as a Qualified Person/ Responsible Person
  • Represent QA at senior management and board
  • Budgetary and managerial responsibility for Quality Assurance
  • Work with other departments to ensure a strong QA culture throughout the business and  provide quality guidance to product development projects and programs.
  • Monitoring performance and directing objectives to maximize profitability
  • Acting as a catalyst for change a

Personal Profile:

  • Self-sufficient, influencing, leadership and management skills.
  • Strong analytical and critical skills to troubleshoot complex problems.
  • Highly responsible and capable to work under pressure to meet deadlines.
  • Ability to prioritize multiple tasks
  • Good team player and collaborative working style with the ability to build partnerships with key stakeholders
  • Excellent organizational, planning and time management skills
  • Detail oriented professional with strong written and oral communication skills.
  • Motivated, proactive, dynamic, methodical, organized and decisive.
  • Ability to absorb, digest and relate detailed scientific, quality, and regulatory information.