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6 дней назад - 12.04.2021

Quality Officer

Oximio

Адрес: Киев

About Oximio

Oximio is a clinical trial services provider contributing to research to find effective treatment and cures for all living beings, globally. Oximio (part of SMO brand) started in 2004, covering multiple geographic areas provides the entire range of logistics services for clinical trials, while ensuring the highest standards of operation in 9 countries. Through its highly experienced and qualified people, Oximio is thoroughly versed in global procedures of clinical trials, and at the same time has extensive local expertise, which ensures an efficient operation and full adaptation to local requirements. Our mission is to provide clinical trial logistic services in an honest and caring way and contribute to curing people by expediting the transformation of IMPs into new medicines

Purpose of the role

We are looking for a Quality Officer who will be part of the Quality Assurance Organization.

  • Implementation and control of compliance with ISO 9001 and GxP requirements.
  • Support and update exsiting QMS.
  • Participate in review and approval of SOP, WI, SF and other documents, that have influence on the SMO-Group Quality system that are aligned to the SMO goals and values in a timely manner.
  • Informing Company’s personnel about new documents issue/ documents update.
  • Conduct training on QMS procedures for new employees and GxP training.
  • Lead client’s external audits, providing documentation required during external audits and assessment, providing response concerning observations occurred during external audit.
  • Evaluate and approve suppliers ensuring that they are aligned to established quality standards.
  • Review and approve Technical and Quality agreements concluded with suppliers ensuring that they are aligned to established quality standards.
  • Prepare internal audits plans/schedules, conducting internal audits and preparation of internal audit reports.
  • Control of CAPA implementation (in the frames of incident reports/ customer complaints/ observations), taking appropriate measures to prevent similar situations in the future.
  • Suggest methods of improvements concerning operational processes to further align practices to quality standards.
  • Implement and maintain regular review and effectiveness estimation of Quality system locally.
  • Maintain QMS documentation in electronic and paper form.

What will you need to be successful in your job?

  • Higher education (Master’s, Specialist’s, Bachelor’s degree).
  • Working experience in Quality sphere at least two-three years.
  • Reliable, punctual and organised.
  • Logical and methodical and exceptional attention to detail.
  • Approachable and able to effectively build honest relationships with a diverse range of people, handling employee matters with the utmost care.
  • Ability to think innovatively to problem solve.
  • Excellent, caring and honest communication skills.
  • Upper-intermediate English level.

Why you should join us?

We value new ideas; innovations and we respect the experience internally and externally that are brought to us. We provide career opportunities in an internationally growing organization by continuously exploring new countries and business opportunities.
The company embraces and encourages diverse perspectives and builds a culture that values work-life integration, professional development and collaboration between countries and functions across the world.
We are offering a flexible learning culture in an international business environment.

Working conditions:

We offer a full-time official employment.

Medical insurance package.

Great management team.

Location: primarly Krushynka village (Kyiv region, nearby Vasylkiv) - 3 times per week. We have a corporate bus (остановки автобуса ст.м. Теремки и Завод «Кулиничи»).

Please, send your English CV with your salary expectations.

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