Senior Pharmaceutical Compliance Specialist

6 days ago


Montreal, Quebec, Canada Pharmascience Full time

About the Role

As a Senior Pharmaceutical Compliance Specialist at Pharmascience, you will be responsible for ensuring the application of Good Manufacturing Practices (GMPs) and international regulatory requirements. Your key responsibilities include reviewing documentation, approving or rejecting lots, performing lot status changes in SAP, contributing to change control and CAPA processes, and preparing certificates of manufacturing for external clients.

Key Responsibilities:

  • Reviewing documentation and approving or rejecting lots according to established checklists
  • Performing lot status changes in SAP
  • Contributing to the implementation of change actions related to product release
  • Coodinating with the supply group to establish priorities for lot release
  • Maintaining reference tables and other communication tools up to date
  • Contributing to various initiatives and projects with multidisciplinary teams
  • Preparing certificates of manufacturing for products sold to external clients
  • Approving quarantine use authorizations
  • Conributing to change control and CAPA processes related to product release

Required Skills and Qualifications:

  • Bachelor's degree in science or related field, or equivalent experience
  • Minimum 2 years' experience in the pharmaceutical industry
  • Bilingual oral and written proficiency in English and French
  • Observation skills, thoroughness, and rigor
  • Able to make decisions and communicate them tactfully and diplomatically
  • Facility to interact and excellent communication skills
  • Planning and organizational skills
  • Competent in MS Office and SAP
  • Ability to write and interpret technical documents

Salary and Benefits: The estimated salary for this role is $65,000 - $80,000 per year, commensurate with experience. Additionally, you will receive a comprehensive benefits package, including health, dental, and vision coverage, as well as a generous retirement plan.



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