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

POLÍTICA DE PRIVACIDADE

A Galenicum Health, S.L. lhe garante que em seu domínio web www.galenicum.com trataremos seus dados com total confidencialidade. Para más información, consulte nuestra política de privacidade.

INFORMAÇÃO BÁSICA SOBRE PROTEÇÃO DE DADOS

Responsável:

Galenicum Health, S.L.

Delegado de Proteção de Dados:

protecciondedatos@galenicum.com

Finalidade:

Gerenciar o relacionamento com os candidatos a um emprego na empresa.

Legitimidade:

Autorização.

Destinatários:

Não serão cedidos os seus dados a terceiros, exceto por obrigação legal.

Direitos dos titulares dos dados:

De acesso, retificação, supressão, portabilidade, limitação do tratamento, e de oposição ao tratamento, contatando por correio eletrônico: protecciondedatos@galenicum.com.

Posições em aberto

Quality Assurance Expert

Quality Assurance Expert

January 11, 2019

Position in organization:

  • Department: Quality Assurance Expert
  • Reporting to: Quality Assurance Manager
  • Staff in charge: -
  • Location: Esplugues de Llobregat

Education / experience:

  • Degree in Pharmacy
  • Master’s degree in Pharmaceutical Industry.
  • Excellent level of English and Spanish, spoken and written.

Previous experience required:

  • GMP knowledge
  • Minimum 3-4 years experience in GMP environment.
  • Minimum 2 years in QC/QA in a Pharmaceutical manufacturing site, preferably with Qualified Person (QP) release responsabilities.
  • Experience MS Office

Roles and responsibilities:

  •  Release activities, by reviewing CoAs, Manufacturing & Packaging Records (BMR, BPR) and management of documentation related.
  • Proposal and management of corrective actions with focus on continuous improvement.
  • Support in the review of Quality Technical Agreements with customers and suppliers.
  • Management of deviations and customer/ suppliers claims. 
  • Management of changes, incidences and nonconformities.
  • Keep updated on GMP regulations and evaluate the impact within our own Quality System and activities.

Personal Profile:

  • Motivated, disciplined, proactive, dynamic, methodical, organized and decisive.
  • Self-sufficient.
  • Strong analytical and problem solving skills.
  • Strong organizational, planning and time management skills, to achieve project timelines.
  • Highly responsible and capable to work under pressure to meet deadlines.
  • Ability to prioritize multiple tasks
  • Detail oriented and good communication and research skills.
  • Capable of working under your own initiative whilst being a good team player.

Pharmacovigilancia Expert

Pharmacovigilancia Expert

January 11, 2019

Position in organization:

  • Department: Clinical Department
  • Reporting to: Clinical Manager and/or Clinical Head
  • Staff in charge: -
  • Location: Office at Esplugues de Llobregat

Education / experience:

  • Pharmacy or life sciences degree
  • Excellent level of business English, spoken and written.
  • Excellent computer skills, specifically Excel, Word, Outlook and Power Point.

Previous experience required:

  • Relevant experience in Pharmacovigilance on EU level
  • Knowledge of EU Pharmacovigilance legislation and preferably experience with data submission to EudraVigilance.
  • The candidate will have a minimum of 2 years of experience in similar functions.

Roles and responsibilities:

  • Role of the qualified person responsible for pharmacovigilance in the EU (QPPV) based on Guideline on good pharmacovigilance practices (GVP).
  • Establishing and maintaining the MAH’s PV system(s): the entire PV/drug safety functioning of the MAH.
  • Ensuring that Quality Control (QC) and Quality Assurance (QA) mechanisms are in place to keep the MAH in compliance.
  • SOPs and Working Documents covering PV are in place, up-to-date, trained on and actually followed.Metrics & KPIs on expedited and aggregate reporting and other key operational functions are tracked.
  • Ensuring that promises made to the Health Authorities in regard to safety are kept.
  • Ensuring that PV training is done in the drug safety/PV department as well as anywhere (everywhere) else in the company (or vendors, third parties etc.) where safety matters may arise
  • Ensuring that written agreements with other companies (including business partners, vendors, other third parties) are in place regarding safety and oversee their work.
  • Ensure that signal detection and trending mechanisms are in place.
  • Ensuring that all suspected adverse drug reactions ADRs received by the MAH are collected and collated and accessible at one or more points in the EU.
  • Ensuring the continuos evaluation of the benefit/risk analyses of all products.
  • Maintaining an overview of the safety profiles and any emerging safety issues on company products.
  • Have access to and ensure that the Pharmacovigilance System Master File (PSMF) is in place, accurate and up to date.
  • Responsible of the training on PhVig matters required for specific areas.

Personal Profile:

  • Highly responsible, proactive, dynamic, methodical, decisive and organized individual.
  • Excellent oral and written communication and interpersonal skills.
  • Strong analytical frame of mind and problem solving.
  • Capable to work under pressure.
  • Strong organizational and time management skills.