QA Specialist - Third Party Reviewer

at  Pharmascience Inc

JOB SUMMARY

As the QA Specialist - Third Party Reviewe, you will act as a compliance resource person to ensure the application of the GMPs as well as all Canadian & International regulatory requirements. You will actively participate in the various quality activities related to the release of products in compliance with marketing authorizations. You will coordinates communications and activities relating to quality and compliance aspects between Pharmascience, Subcontractors and Clients.

SKILLS, KNOWLEDGE & ABILITIES:

• Minimum BA in science or related discipline or experience considered as equivalent.
• Minimum 2 years’ experience in the pharmaceutical industry
• Bilingual oral and written (English / French) as the incumbent will have to communicate with suppliers located outside the province of Quebec
• Observation skills, thoroughness and rigor
• Capacity to take decisions and to communicate them with tact and diplomacy
• Facility to interact and excellent aptitude to communicate with people
• Planning and organizational skills
• Competent with MS Office, SAP an asset
• Ability to write & interpret technical documents.

EXPERIENCE

Required

• 2 year(s): Experience in the pharmaceutical industry

EDUCATION

Required

• Bachelor or better in Science or related field

• Review the documentation and approve or reject lots according to the established checklists
• Perform lot status changes in SAP
• Contribute in the implementation of the change actions related to the release.
• Coordinate with the supply group to establish the priorities of the lots to release
• Keep reference tables and other communication & priorization tools up to date.
• Contribute effectively in various initiatives and projects with multidisciplinary teams.
• Prepare Certificate of Manufacturing for products sold to external clients
• Approve Quarantine Use authorizations
• Contribute to the Change Control and CAPA processes with respect to release activities.