Specialist QA - R&D

June 10 2019
Industries Pharmaceutical, Biotechnology
Categories Pharma, Biotech, Sciences, R&D, Project - Project management - Planning, Research & development, Quality assurance and control - Validation, Research and development
Montreal, QC

Omega is offering you!

  • dynamic & collaborative work team!
  • Growing company.
  • Safe working environment.
  • Flexibility of schedule.
  • Group insurance.
  • Group RRSP with employer contribution.
  • Train and public transport nearby.

What will you have to do?

  • Participate in the establishment, maintenance and continuous improvement of a specialized quality system to support R&D programs.
  • Actively participate as a quality support in R&D and technology transfer activities as well as technical projects under the responsibility of the Scientific Affairs Department.
  • Approve laboratory investigation reports (OOS) and incident reports related to R&D activities. Supervise and provide guidance for investigations and carry them out if necessary.
  • Make the approval of:
    • R&D specifications and methods as well as method validation reports.
    • Development and technology transfer reports, method validation reports, master development files.
    • Master development and technology transfer files (engineering, submission).
    • The R&D stability program
    • PSURs
  • Support and participate in quality-related training initiatives.
  • Review laboratory, engineering and bid batch documentation for completeness, accuracy and compliance with process parameters.
  • Participate in activities related to process improvement and R&D document approval: approve product non-conformity or non-quality investigations; monitor corrective and preventive actions following an incident; collaborate in process optimization; review standard operating procedures; collaborate in internal and external audits.
  • Perform any other related tasks deemed relevant to the position.

We would like to meet you if you have:

  • Bachelor Degree in Science or related field (chemistry, biochemistry, biology, etc.).
  • Minimum of 5 years in the pharmaceutical industry.
  • At least 2 years of experience in quality assurance or GMP in pharmaceutical development or regulatory affairs. 
  • Knowledge of Canadian and American regulations is an asset.
  • Ability to work in a team environment.
  • Organizational skills.
  • Good judgment and observation skills.

We know that responding to a job offer is a lot of work and we sincerely appreciate the time you spend with us. Emilie will be happy to consider your application.

Apply now!

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