Global Quality Assurance (QA) Professional

Type of job: full-time

Our client is a European biotech company with a global reach. The strategy of our client is to establish itself as an original biotech/pharmaceutical firm with global presence.

Qualification/background

• Advanced (preferably) degree in healthcare related field (MD, PharmDr, Life Science)
• Experience with quality assurance/GCP auditing in biopharmaceutical industry (including CA, CRO, BioPharma) in clinical development
• GCP knowledge, certified auditor

Responsibility/key activities

• QA system
• GCP related audits (internal documents/systems/procedures, CROs, PV, Vendors, Sites)
• Audit's reports and CAPA tracking
• Compliance with external regulation of QA in clinical development in Europe, USA
• Readiness for QA/GCP inspections
• Involvement with QA/GCP inspections
• Liaising with external parties
• QA auditing vendor management
• QA risk assessment and risk minimization
• QA training and education
• QA SOPs and WIs
• QA budget
• Reporting to CEO/Board member
• Independent to Clinical Operations

Skills/knowledge/competences:

• GCP Guidelines
• Fluent Czech, English - spoken and written (+ writing skills)
• Ability and willingness to learn
• Willingness to travel (Europe, US)
• Communication and interpersonal skills
• Time management, structured, organized, able to work independently
• Mature personality - credible, reliable
• Result oriented
• Attention to detail
• Empathy, Diplomacy
• Ability to critically review documents
• ICT (MS Office, IN)

Organizational:

• Reporting to CEO/Board member (other than CD&MO)
• Independent to Clinical Operations (CDMA&L)

Scope: Czech Republic, Europe, USA

If you are interested in the given opportunity, please send your resume to the email adress.

E-mail:
tomas.prajzler@talentor.com

Updated: 10.7.2013