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Quality Assurance Specialist από την εταιρεία HEXOMED

Πλήρης Απασχόληση
Aghia Paraskevi

Περιγραφή Θέσης

This is an opportunity for a Quality Assurance professional to get involved and make a mark in the fastest growing industry world wide. HEXOMED is a fast growing vertically integrated medical cannabis company headquartered in Athens Greece.

The Quality Assurance Specialist will be principally responsible for overseeing all quality assurance procedures. At the pre-operational phase of HEXOMED the QA is expected (among other things) to:

  • Develop SOPs and quality manuals assisted by our professional advisors.
  • Develop a quality assurance program.
  • Assist the GMP project team during project planning and execution.
  • Provide risk assessment & impact analyses during project stage about the design inputs from the engineering firm.

During normal operations the QA will assume all the day to day QA regular responsibilities including being responsible for the adherence to and implementation of quality assurance and control systems, developed in strict compliance with regulations and guidelines. The QA will also be responsible for overseeing all quality control issues such as audits, investigations, etc.


Requirements

The successful candidate should have a minimum of 5 years' experience in QA of a manufacturing facility and experience with documentation in a QMS system.

The successful candidate should have knowledge of:

  • GMP requirements (preferable, will otherwise be trained by external consultants)
  • HVAC qualification
  • Production room design from QA point of view
  • QbD - quality by design
  • Risk assessment & impact analyses during project stage about the design inputs from the engineering team
  • Regulation requirements of EMEA(2008)
  • Quality systems such as: change control, deviation
  • Man, material, flows, waste- flows design & their future impact on operations & GMP
  • Equipment layout, material flow fits, impact on GMP during operations
  • Good documentation practices
  • Pharmaceutical experience a plus

Κωδικός αναφοράς

EDBEA15DB0

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