Compliance & Quality Manager

3 weeks ago

Montreal, Canada Pharmascience Inc. Full time
Description

The Compliance & Quality Assurance Manager is responsible for the approval and management of the stability samples, annual product quality Review (APQR), the change controls, the inspection and sampling of incoming materials, internal audit, client audit as well as the review of quality systems (Quality Management Review). He ensures the application and surveillance of the various systems for Royalmount site to meet the regulatory requirements and the procedures in force.

Responsabilities & Duties

Quality System Management :

  • Define, manage, monitor and maintain quality systems processes
  • Establish and monitor continuous improvement objectives with his team
  • Participate in audit (client ulatory agency) as an SME on quality systems or as a member of the host team
  • Track priorities and compile results (KPI)
  • Provide support as a QA expert for business activities
  • Support the QA inspectors’s team by contacting the suppliers in case of non -conformities, being the contact point with the procurement ‘s team for all questions related to quality
  • Revise & approve the complaints
  • Approve APQR
  • Put in place and management of internal audit program
  • Approval of procedures & all work documents
  • Maintain and manage the Quality Management Review meeting (QMR) for the Royalmount site
  • Participate in the hiring process, trains and evaluates the performance of the personnel under his supervision
  • Plan and prioritize to ensure the team functions optimally
  • Develop and motivate his team to ensure that objectives are reached
  • Contribute to the maintenance of a harmonious working environment and team spirit within his team
  • Fluent in English and French (oral & written)
  • Great Knowledge in GMP
  • Knowledge in different product forms and manufacturing packaging processes
  • Simplification & improvement of quality systems
  • Planning and organizational skills
  • Autonomy
  • Cpacity to effectively manage time and priorities
  • Positive attitude toward change and ability for innovation
  • Great skills with MS Office
QualificationsEducationRequired

Bachelor or better in Science or related field.

ExperienceRequired5 years:

5 years: 5 years of experience in performant team management

5-10 years:

5-10 years: 5 to 10 years of experience in the pharmaceutical industry

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