Quality Assurance Specialist

Firma Bilgisi Gizli

Job Description:

QUALITY ASSURANCE SPECIALIST will be responsible for development, implementation and maintenance of quality management system at Clinical Research Organisation (CRO) in accordance with ICH-GCP (International Clinical Harmonization-Good Clinical Practice) and other national and international quality regulations.

QUALITY ASSURANCE SPECIALIST will promote achievement and improvement of general quality principles throughout the organisation and report directly toManaging Director.

The candidate will be responsible for creating, maintaining and revising of Standard Operating Procedures(SOPs),performing Vendor Assessments on behalf of Clinical Research Organisation, performing internal and external audits, maintaining the folders for essential company documents (such as personnel CVs, Job Descriptions, organizational chart, SOP index, etc.),  providing support when audits or inspections from Health Authorities and Sponsors take place and coordinating complaint management processes.

Training the teams for procedures will be one of the main tasks in addition to above work definitions.

Qualifications:

We are looking for candidates to become a team member for our Organisation

A successful candidate should have:

• University degree in Medical Sciences (Pharmacy, Biology, Chemistry, Genetics, Medicine or a related field)
• Preferably 2-3-year experience in clinical studies and/or pharmaceutical industry (GMP knowledge will be an asset)
• Good knowledge of ICH-GCP and quality activities in clinical studies
• Standard quality management system experience (ISO)
• Previous audit experience,
• Excellent command of written and spoken English,
• Good knowledge of MS Office applications,
• Strong management skills compatible with strong teamwork,
• Organised, creative and confident with good communication skills,
• Good time management,
• Excellent presentation, planning and organization skills,
• Exceptional attention to detail.