Quality Assurance and Pharmacovigilance specialist

October 10 2019
Industries Pharmaceutical, Biotechnology
Categories Pharma, Biotech, Sciences, R&D, Quality assurance and control, Validation, Pharmacovigilance
Laval, QC

MAIN TASKS:

  • Quality Assurance:

    • Revision of batch records and monitoring of master document;
    • Writing and monitoring of SOP;
    • Writing and revision of validation and stability protocols;
    • Monitoring of quality complaints, deviations, CAPA and change control systems;
    • Monitoring of retains and stability samples;
    • All other functions related to GMP compliance.
  • Pharmacovigilance:
    • Periodic literature review;
    • Receipt and evaluation of the adverse events reports, writing of the CIOMS;
    • Follow-up on the received adverse events;
    • Review and preparation of the annual pharmacovigilance reports.

REQUIREMENTS:

  • Bachelor degree in Science or in a related field;
  • Perfect knowledge of GMP;
  • Minimum of 3 years' experience in the pharmaceutical industry;
  • Perfectly bilingual (English & French);
  • Ability to work under minimal supervision (Tele-working);
  • Ability to monitor multiple priorities and strong organizational skills;
  • Excellent written and verbal communications.
Apply now!

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