Quality Assurance Specialist

Position Summary

Participation in implementation, maintenance, development and monitoring of quality systems assuring compliance to GxP requirements.

Key Activities and Responsibilities

  • Owner of assigned quality systems
  • Review and approval of quality relevant documents (SOPs, validation documents, CAPA files, deviations, etc.)
  • Review and approval of risk analyses and documents related to computerized systems validation and surveillance
  • Coordination of risk analyses
  • Coordination of audits
  • Performing internal and external audits
  • Coordination of training, performing staff training on GxP topics
  • Participation in quality related projects
  • Responsibility for the management of databases for various quality systems (CAPA, deviation management, change management, risk management, audits, documentation management, training, validation, etc.
  • Continuous self-education in GxP requirement and in manufacturing process

Competences, Skills and Qualification

Minimum Qualification

  • University degree – science
  • Advanced knowledge of English
  • Detail oriented person
  • General knowledge of quality systems in pharmaceutical manufacturing (cGMP)
  • Proficient in Microsoft Office: Word, Excel, PowerPoint, etc.
  • Autonomous, proactive, consistent person
  • Team player with good communication capabilities
  • Good organizational skills

Preferred Qualification

  • Experience in Quality Assurance
  • Knowledge of validation principles and experience in performing validation of computerized systems / equipment / analytical methods / process
  • Practical experience with risk management tools (FMEA)
  • Experience in project management
  • SharePoint knowledge

Other Requirements

  • Knowledge of ISO systems is an advantage
  • Ability to manage changing priorities within a highly dynamic environment
  • Ability to work well under deadlines

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