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Quality Assurance Technician - Spain  

3pbio (company)


Posted on : 27 June 2017

Project Description

  • The candidate will be expected to be key member of the Quality Assurance.
  • The candidate will be expected to provide quality assurance oversight.
  • Proficiency and capability in managing activities in a fast paced environment is expected.

Assessment criteria:
  • At least three years’ experience in Quality Assurance from a related industry, with a preference from within the biopharmaceutical industry. 
  • Draft quality assurance policies and procedures 
  • Experience training staff in Quality Assurance 
  • GMP experience 
  • Audit experience 
  • CAPA experience 
  • Ensuring Deviations, CAPA and Change Control are progressed in a compliant and timely manner 
  • Ensuring complaints and non-conformance issues are investigated in a compliant and timely manner 
  • Ensuring batches are reviewed and released as required to support business needs 
  • Participating and supporting internal audits 
  • Participating and leading risk assessments 
  • Knowledge of tools, concepts and methodologies of QA 
  • Capable to identify areas for improvement in the quality system and implement improvement actions 
  • Knowledge of relevant regulatory requirements 
  • Proficient verbal and written communicator. 
  • Proficiency to work within regulatory guidelines. 
  • Proven initiative and independent thinking to deliver tasks on time, whilst working in a team environment. 
  • Experience in the preparation and review of documentation (SOPs, Development Reports, Characterization Reports, Qualification reports, Validation Reports) in English to regulatory standards is essential. 

Other requirements: 
  • Fluent in English.