Part-time Quality Assurance Officer at Good Biomarker Sciences

JOB DESCRIPTION

GBS Leiden is looking for a part-time Quality Assurance Officer who will be responsible for ensuring a product or service meets the established standards of quality including reliability, usability and performance. The ideal candidate is a reliable and competent professional whose approval will be necessary for the continuation of a project life cycle.

ESSENTIAL DUTIES & RESPONSIBILITIES

  • Devise procedures to inspect and report quality issues
  • Monitor all operations that affect the quality
  • Devise sampling procedures and directions for recording and reporting quality data.
  • Assure the reliability and consistency of project workflow by checking processes and final output.
  • Report all deviations to executives to ensure immediate action.
  • Performance of Deviation management, Corrective and Preventive Actions (CAPA), as well as Change Control
  • Facilitate proactive solutions by collecting and analyzing quality data
  • Review adequacy of quality assurance standards and policies
  • Keep records of quality reports, statistical reviews and relevant documentation
  • Coordinate and support on-site audits conducted by external providers
  • Audits
  • Evaluate audit findings and implement appropriate corrective actions
  • Facilitating Standard Operating Procedures (SOPs) and Guideline Development
  • Other duties may be assigned.

REQUIREMENTS

  • Bachelors or Master degree preferred
  • Quality inspection, auditing and testing experience in the field of life sciences (3-5 years)
  • QA certification is an advantage
  • Knowledge of tools, concepts and methodologies of QA & knowledge of relevant regulatory requirements (GCLP, GCP, GLP)
  • Excellent numerical skills and understanding of data analysis/statistical methods
  • Strong computer skills including Microsoft Office and databases

 

KEY COMPETENCES

  • Attention to detail
  • Outstanding  verbal and written communication skills (Dutch & English)
  • Excellent organizational and planning abilities
  • Reliable and trustworthy
  • Strong teamwork ethics

Contact person: Petra de Kruijf, p.dekruijf@gbsleiden.nl, 071-751 71 79

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