Quality Assurance & Compliance Specialist/Manager

Excelya>Full-time>Quality Assurance & Compliance Specialist/Manager

Job description

EXCELYA, the fastest growing European CRO with 24 offices across Europe, expands its Quality Assurance Department and is looking for an experienced Quality Assurance & Compliance Specialist/Manager to join our EU team and support the Group QA team.

Are you ready to make your next career step and join EXCELYA on its way to become the Leading CRO in Europe?

Key responsibilities:

  • Perform gap analysis and define required actions
  • Follow up on CAPAs management and on time implementation
  • Ensure third parties compliance through qualification and evaluation process
  • Conduct vendor audits
  • Perform internal audits, prepare reports and ensure inspection readiness
  • Accommodate client audits and reply to audit reports
  • Follow-up and ensure fulfillment of KPIs
  • Provide guidance and training to other members on selected topics
  • Assist in computer system validation

Required Skills & Knowledge:

  • University Degree in life science, post graduate studies in a relative field are considered as a plus
  • At least 3 years of relevant experience in clinical research with very good knowledge of applicable regulations and guidelines (experience as Compliance Specialist or Clinical Project Leader will be considered as a plus)
  • At least 3 years of experience in Quality Assurance department of a CRO company with involvement in compliance
  • Knowledge and experience of QMS maintenance and SOPs writing
  • Excellent communication and strong interpersonal and organization skills
  • Self-motivated, able to work effectively under pressure independently and within teams in a highly demanding multinational working environment
  • Ability to multi-task with quality deliverables, prioritize effectively and ensure delivery on time
  • Strong results’ orientation personality, Open-minded and passionate about new challenges
  • Excellent command of the Greek and English languages (both verbally and written)
  • Excellent knowledge of MS Office

 

The position will report directly to the group QA Director and will be applicable for Excelya group.

 

Join us for a challenging career!

The company offers a competitive remuneration package, as well as continuous development and rewarding career opportunities in an exciting, international and supporting working environment.

At EXCELYA sustainable careers flourish, as we care about what you can be and how fast you can reach higher international positions.

The position can be based in UK, Greece or Benelux

Please send your application to: mounnouch@excelya.com ; 

 

Become an Excelyate!

Excel with care!

Summary

Contact

Apply for this job