Job description

Project Manager in QA

Location :
Kharkiv
We are ready to offer :
  • Competitive salary based on your experience level
  • Professional and career growth opportunities
  • Opportunity to work and communicate directly with the customers
  • Your health support via gym compensation and vacation policy
  • Free English classes twice a week in the office
  • Leisure activities in the office: X-box, table tennis, cinema tickets, tea time, pizza days
  • Parking zone
About the work :
  • The role it intended to multiple challenging activities/ projects in pharmaceutical, biotech and medical device companies.
  • The Role includes supporting and leading quality systems, including building, maintaining and improving.
  • Supporting and improving production activities including preforming audits in production process and handling deviations.
  • Improving production process examples:
  • Final product quality, Handling deviations.
  • Handling deviation activities.
  • Good knowledge of TMV and production engineering.
  • Supplier quality
  • Deep understanding of development process (Design control)
  • Documenting results/ audits.
  • Reporting to: vice president of Quality, regulation, Clinical and regulation
About the project :

Our client provides an umbrella of services to the Pharmaceutical, Biotechnological, Medical Device companies during their different lifecycle stages incorporating end-to-end project activities while adhering to the regulatory requirements.

Our client integrates operational compliance, quality, regulatory, self-developed solutions as well as technology in ways that master complex business challenges to help its Life Science customers exploit their existing strengths and develop new capabilities.

 

Requirements :

 

  • B.S.c in Engineering, chemistry, Biotechnology, LiveScience.
  • 3 Year  experience in the field of Pharmaceutical, Biotech, Medical devices
  • Experience in medical devices (At least two years) in ISO13485 environment GMP, 21CFR Part 820 in the quality department.
  • Experience in the quality and regulation requirements.
  • English – Upper-intermediate
  • The ability to write acceptance test for process, reception, managing MRB processs and approve deviations – working along side with development and production departments.
  • Experience in writing and integrating quality systems in organizations according to standards.
  • Ability and experience in working  along side and support manufacture and development departments.
  • Experience in writing and integrating quality systems in organization according to ISO13485, ISO9001, ICH.
  • The Job might require traveling.
  • The ability to work independently is curtail.

 

 

Expected day-today :
  • Weekly feature review meetings – via video chat.
  • Weekly sprint planning / adjustment meetings – via video chat.
  • Daily standup meeting (Scrum style) via video chat / text chat.
  • We prefer working in weekly sprints, deploying every two weeks.
our office life

WHAT WE OFFER

  •  Beautiful and
comfortable offices Beautiful and
    comfortable offices
  • Convenient work
schedule Convenient work
    schedule “Good morning”
  •  Opportunity to manage
your work time independently Opportunity to manage
    your work time independently
  •  English speaking club, tea day,
pizza day and many other events in office English speaking club, tea day,
    pizza day and many other events in office
  • Interesting projects
and opportunity for career growth Interesting projects
    and opportunity for career growth
keep in touch
Herzliya Pituach, Israel
Kharkiv, Ukraine
Kyiv, Ukraine
contact us





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